ARCHIVED Authorized medical devices for uses related to COVID-19: List of authorized testing devices

Notice to Reader:

This is an archived page. Please refer to the current version of the List of authorized medical devices under Part 1.1 of the MDR.

The list of authorized testing devices has been updated to include the available instructions for use for COVID-19 tests. Please refer to this section for more information before searching for the COVID-19 test you are looking for.

* Point-of-care testing devices (rapid tests) and self-testing devices totals include antigen, nucleic acid (PCR) and serological testing devices.

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Authorization of COVID-19 testing devices

Health Canada has authorized a variety of COVID-19 tests based on data supporting their intended use.

Each test is authorized for:

Using testing devices as directed

Always follow the instructions contained in your test kit or provided by your local health authority. The instructions tell you how to collect a sample and take the test. They are written specifically for that type of kit. If you take a sample in a different way, your test result may be inaccurate.

Health Canada works closely with manufacturers and public health partners to ensure the most up-to-date information is made available.

The Canadian Agency for Drugs and Technologies in Health (CADTH) conducted an environmental scan related to sample collection for testing during the Omicron variant. They looked at scientific literature as well as recommendations in Canadian and international jurisdictions. We reviewed these findings and continue to recommend that COVID-19 testing devices be used according to the instructions contained in the test kit.

Review the full CADTH report titled Self-collection of nose and throat swab samples for SARS-CoV-2 antigen testing.

Medical device incidents

If you have witnessed or experienced a problem with a medical device, including a COVID-19 test, you should report it. You should report the problem directly to the manufacturer of the test. Look for contact details for the manufacturer on the box and/or the test's instructions for use.

You may also report your concern directly to Health Canada.

Understanding the "testing information" column

For each device, the following table identifies the authorized technology type, intended setting(s), sample type(s), intended population(s), shelf life and sensitivity.

Technology types

Intended setting

Devices may be authorized for more than 1 type of setting. For example:

Refer to the point-of-care or self-testing webpage for more information.

Sample type

Devices may be authorized for multiple sample types and can include the following:

For specific sample collection methods, look for the instructions for use provided for each specific device.

Intended population

Devices have been authorized for use by different types of patients. The following table indicates all authorized patient types, along with any differences in the sensitivity values associated with the intended population:

Shelf life

The following table indicates the most recently authorized shelf life of a device. Extensions for shelf life may be granted:

For more information on tests that may have an expanded use indication, please visit:

Health Canada continues to work closely with our federal, provincial and territorial partners, and the manufacturing community, to support additional shelf life extensions.

Sensitivity

Sensitivity values are presented to provide transparency around clinical performance data that were filed with Health Canada at the time of submission. Sensitivity is a measure of the accuracy of a test against a reference standard. Only the most conservative values pertaining to SARS-CoV-2 are presented where either:

Tests that identify antibodies (serological tests) do not have their sensitivity value posted in the table. The sensitivity value for these tests depends on many factors. For more information, please consult the instructions for use provided with your test. For serological tests within the testing information column, the target epitope will be identified instead of sensitivity.

Tests that identify antibodies to the spike protein of the SARS-CoV-2 virus, however, will be unable to distinguish between people who have been infected and who have been vaccinated.

Variants

Variants of a virus are versions of the virus in which the nucleic acids are different. Variants can impact the performance of a test. A false negative result can occur with any test. However, the test is more likely to give a false negative result if what it detects is changed as a result of the differences in the variant.

The impact of variants on each test will depend on:

A negative test result should be considered along with a person's symptoms, history of exposure to the virus and the variant of virus that is common in their area.

Given that virus variants are common and expected, Health Canada continues to review available information. We are working with other regulators and manufacturers of COVID-19 test devices to monitor any impact that variants may have on the ability of diagnostic tests approved by Health Canada to detect COVID-19 variants. If an issue is identified, we will work quickly with manufacturers and public health laboratories to mitigate those risks.

Additional attributes

The table also indicates if the following apply to any of the authorized devices:

Visual read versus instrument read

Results of the COVID-19 test can be displayed:

The testing information column indicates if the test can be read on an instrument or visually as follows:

Multiplex

Some COVID-19 testing devices allow for other respiratory viruses (for example, influenza A and B and RSV) to be detected at the same time. These tests are indicated by the term multiplex.

Self-collection

Some COVID-19 testing devices may be used by a person to collect their own nasal or saliva samples under the supervision of a health care provider. These testing devices only apply to point-of-care and lab-based tests, as self-tests do not require supervision by a health care provider.

Sample pooling

Some COVID-19 testing devices make it possible to pool samples together for testing, but this strategy will differ from test to test. For more information, please consult the "instructions for use" on how sample pooling may be used with the relevant testing device.

Expanded use

Part 1.1 of the Medical Devices Regulations permits the authorization of new COVID-19 uses for devices already approved in Canada when scientific data supports this. COVID-19 testing devices that have received an expanded use authorization will show the symbol EU. The List of Medical Devices for Expanded Use in Relation to COVID-19 provides additional information on the expansion of use for specific COVID-19 testing devices.

Authorized instructions for use

To help consumers use COVID-19 testing devices safely and effectively, we have published available authorized instructions for use (IFU) for authorized devices.

To access the relevant IFU for that device, please click on the hyperlink in the "device identifier" column in the following table.

Please note that not all device identifiers will have an IFU.

Some devices will have multiple versions of IFUs for a single device to account for different configurations of their test kit. For example, an authorization can have a nasal version and a nasopharyngeal version, each with its own device identifier and IFU.

Manufacturers of self-testing devices must provide IFUs in both official languages as part of the authorization review process. However, manufacturers of testing devices intended for use only in a point-of-care or lab setting do not have to submit their IFUs in both official languages.

The manufacturer is responsible for providing accurate translation of the approved IFU into the second official language.

Please note that for recently authorized devices, there may be a delay in posting the IFU in both official languages due to translations and finalization of the labelling.

If an IFU is available in only 1 official language, contact the manufacturer to request it in the other official language.

Authorized testing devices list

The entries in this list represent each individual device identifier included on each authorization. In other words, a single authorization may be for multiple devices, such as a testing device and control kits, that are meant to be used together to conduct the test.

Within the authorization, each device is listed separately. The "Authorization date" column indicates the first date that the testing device was authorized for sale. Manufacturers may amend their authorizations to add additional devices over time. The date that new device identifiers are added is reflected in the "device first issued" column.

COVID-19 testing device applications authorized by Health Canada
IO authorization date IO authorization ID Manufacturer Device name Device identifier Device first issue date Testing information
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas Buffer Neg Control Kit 9051953190 2023-09-29 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 9343733190 2021-06-08 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 Asap 12.5.0 9795570001 2023-09-29 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 Control Kit 9175440190 2020-03-17 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 Qualitative 9446109190 2023-09-29 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 Qualitative 9448870190 2023-09-29 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 Qualitative Control Kit 9446117190 2023-09-29 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 Test 9175431190 2020-03-17 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Cobas Scov2-Ql Asap 12.4.0 9812091001 2023-09-29 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-17 312730 Roche Molecular Systems, Inc (United States) Sw Cobas 5800 Scov2-Ql Asap Version 1.3.0 9814833001 2023-09-29 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Asymptomatic Instrument Read Shelf Life: 12 Months Sensitivity: 98.7% (Np), 96.2% (Nasal)
2020-03-18 312749 Life Technologies Corporation (United States) Applied Biosystems COVID-19 Interpretive Software COVID-19 SOFTWARE V1.3 2020-10-05 Nucleic Acid Technology Lab-Based Test Nasal, Np, Saliva Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 98.6% (Symptomatic)
2020-03-18 312749 Life Technologies Corporation (United States) Applied Biosystems COVID-19 Interpretive Software COVID-19 SOFTWARE V2.3 2020-10-05 Nucleic Acid Technology Lab-Based Test Nasal, Np, Saliva Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 98.6% (Symptomatic)
2020-03-18 312749 Life Technologies Corporation (United States) Taqpath COVID-19 Combo Kit A47814 2020-03-18 Nucleic Acid Technology Lab-Based Test Nasal, Np, Saliva Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 98.6% (Symptomatic)
2020-03-18 312749 Life Technologies Corporation (United States) Taqpath COVID-19 Control Dilution Buffer A48002 2020-08-17 Nucleic Acid Technology Lab-Based Test Nasal, Np, Saliva Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 98.6% (Symptomatic)
2020-03-18 312749 Life Technologies Corporation (United States) Taqpath COVID-19 Control Kit A48003 2020-08-17 Nucleic Acid Technology Lab-Based Test Nasal, Np, Saliva Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 98.6% (Symptomatic)
2020-03-18 312749 Life Technologies Corporation (United States) Taqpath COVID-19 High Throughput Combo Kit A49869 2021-01-21 Nucleic Acid Technology Lab-Based Test Nasal, Np, Saliva Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 98.6% (Symptomatic)
2020-03-18 312749 Life Technologies Corporation (United States) Taqpath COVID-19 Rt-PCR Kit A47817 2020-08-17 Nucleic Acid Technology Lab-Based Test Nasal, Np, Saliva Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 98.6% (Symptomatic)
2020-04-05 312756 Solgent Co., Ltd. (South Korea) Diaplexq Novel Coronavirus (2019-NCoV) Detection Kit SQD52-K020 2020-04-05 Nucleic Acid Technology Lab-Based Test Np, Op, Sputum Symptomatic, Instrument Read Sensitivity: 100% (Symptomatic)
2020-04-05 312756 Solgent Co., Ltd. (South Korea) Diaplexq Novel Coronavirus (2019-NCoV) Detection Kit SQD52-K100 2020-04-05 Nucleic Acid Technology Lab-Based Test Np, Op, Sputum Symptomatic, Instrument Read Sensitivity: 100% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Aptiman Oil Reagent Kit PRD-04304 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Panther Fusion Oil PRD-04335 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Panther Fusion Open Access Rna/Dna Enzyme Reagent Cartridge PRD-04303 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Panther Fusion SARS-CoV-2 Assay Controls PRD-06404 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Panther Fusion SARS-CoV-2 Elution Buffer PRD-04334 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Panther Fusion SARS-CoV-2 Extraction Reagent-S PRD-04331 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Panther Fusion SARS-CoV-2 Internal Control-S PRD-04332 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-25 312758 Hologic, Inc. (United States) Panther Fusion SARS-CoV-2 Primer Probe Reagent PRD-06391 2020-03-25 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op, Bal, Bronchial Wash Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 100.0% (Symptomatic)
2020-03-27 312781 Luminex Molecular Diagnostics, Inc. (Canada) Nxtag Cov Extended Panel I054C0463 2020-03-27 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Instrument Read Shelf Life: 18 Months Sensitivity: 92.3% (Symptomatic)
2020-03-25 312783 Diagnostic Hybrids, Inc. - Also Trading As Quidel Corporation (United States) Lyra SARS-CoV-2 Assay M120 2020-03-25 Nucleic Acid Technology Lab-Based Test Shelf-Life: 24 Months Nasal, Np, Op Instrument Read Sensitivity: 100.0% (Symptomatic)
2020-04-19 312821 Becton Dickinson And Company (Bd) (United States) Bd SARS-CoV-2 Reagents For Bd Max System 445003-01 2020-11-02 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Instrument Read Shelf Life: 6 Months Sensitivity: 95.0% (Symptomatic)
2020-03-24 312836 Cepheid (United States) Xpertxpress SARS-CoV-2 XPRSARS-COV2-10 2020-03-24 Nucleic Acid Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Instrument Read, Eu Shelf Life: 18 Months Sensitivity: 97.8% (Symptomatic)
2020-03-25 312977 Abbott Molecular Inc. (United States) ABbott Realtime SARS-CoV-2 Amplification Reagent Kit 09N77-090 2020-03-25 Nucleic Acid Technology Lab-Based Test Np, Op Symptomatic, Instrument Read Shelf Life: 18 Months (Reagents), 12 Months (Controls) Sensitivity: 100.0% (Symptomatic)
2020-03-25 312977 Abbott Molecular Inc. (United States) ABbott Realtime SARS-CoV-2 Application Cd-Rom 09N77-001 2020-03-25 Nucleic Acid Technology Lab-Based Test Np, Op Symptomatic, Instrument Read Shelf Life: 18 Months (Reagents), 12 Months (Controls) Sensitivity: 100.0% (Symptomatic)
2020-03-25 312977 Abbott Molecular Inc. (United States) ABbott Realtime SARS-CoV-2 Control Kit 09N77-080 2020-03-25 Nucleic Acid Technology Lab-Based Test Np, Op Symptomatic, Instrument Read Shelf Life: 18 Months (Reagents), 12 Months (Controls) Sensitivity: 100.0% (Symptomatic)
2020-04-09 313001 Seegene Inc. (South Korea) Allplex 2019-NCoV Assay RP10243X 2020-04-09 Nucleic Acid Technology Lab-Based Test Np, Op, Sputum Symptomatic, Instrument Read Shelf Life: 8 Months Sensitivity: 100% (Symptomatic)
2021-02-10 313054 Sd Biosensor, Inc. (South Korea) Standard COVID-19 AGControl C-NCOV-01G 2021-02-10 Antigen Technology Lab-Based And Point Of Care Test Np Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 86.2% (Symptomatic)
2021-02-10 313054 Sd Biosensor, Inc. (South Korea) Standard Q COVID-19 AGTest Q-NCOV-01G 2021-02-10 Antigen Technology Lab-Based And Point Of Care Test Np Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 86.2% (Symptomatic)
2021-02-12 313076 Btnx Inc. (Canada) Rapid Response COVID-19 IgG/IgM Rapid Test Device COV-13C25 2021-02-12 Serological Technology Lab-Based And Point Of Care Test Fingerstick Blood, Venous Whole Blood, Serum, Plasma Visual Read Shelf Life: 24 Months Target: IgG (S Protein); IgM (S Protein)
2020-04-09 313264 Diasorin Molecular Llc (United States) Simplexa COVID-19 Direct Assay MOL4150 2020-04-09 Nucleic Acid Technology Lab-Based Test Nasal, Nasal Wash/Aspirate, Np, Bal Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 96.7% (Symptomatic)
2020-04-09 313264 Diasorin Molecular Llc (United States) Simplexa COVID-19 Positive Control Pack MOL4160 2020-04-09 Nucleic Acid Technology Lab-Based Test Nasal, Nasal Wash/Aspirate, Np, Bal Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 96.7% (Symptomatic)
2020-09-25 313727 Euroimmun Medizinische Labordiagnostika Ag (Germany) Anti-SARS-CoV-2 Elisa (IgG) EI 2606-9601 G 2020-09-25 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein)
2020-06-11 313812 Luminex Corporation (United States) Aries SARS-CoV-2 Assay 50-10047 2020-06-11 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Instrument Read Shelf Life: 5 Months Sensitivity: 100.0% (Symptomatic)
2020-05-27 314249 Qiagen Gmbh (Germany) Qiastat-Dx Analytical Module 9002814 2020-05-27 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 5 Months Sensitivity: 100.0% (Symptomatic)
2020-05-27 314249 Qiagen Gmbh (Germany) Qiastat-Dx Analyzer 1.0 9002824 2020-05-27 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 5 Months Sensitivity: 100.0% (Symptomatic)
2020-05-27 314249 Qiagen Gmbh (Germany) Qiastat-Dx Operational Module 9002813 2020-05-27 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 5 Months Sensitivity: 100.0% (Symptomatic)
2020-05-27 314249 Qiagen Gmbh (Germany) Qiastat-Dx Respiratory SARS-Co V-2 Panel 691223 2020-05-27 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 5 Months Sensitivity: 100.0% (Symptomatic)
2020-05-12 314838 Diasorin Inc. (United States) Liaison Control SARS-CoV-2 S1/S2 IgG 311461 2020-05-12 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein); IgM (S Protein)
2020-05-12 314838 Diasorin Inc. (United States) Liaison SARS-CoV-2 S1/S2 IgG 311460 2020-05-12 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein); IgM (S Protein)
2020-05-14 314941 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Calibrator Kit 06R8601 2020-05-14 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (N Protein)
2020-05-14 314941 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Control Kit 06R8610 2020-05-14 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (N Protein)
2020-05-14 314941 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Reagent Kit 06R8620 2020-05-14 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (N Protein)
2020-05-14 314941 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Reagent Kit 06R8630 2020-05-14 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (N Protein)
2020-06-05 314982 Roche Diagnostics Gmbh (Germany) Elecsys Anti-SARS-CoV-2 9203079190 2020-06-05 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 9 Months Target: IgG (N Protein)
2020-06-05 314982 Roche Diagnostics Gmbh (Germany) Elecsys Anti-SARS-CoV-2 9203095190 2020-06-05 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 9 Months Target: IgG (N Protein)
2020-06-05 314982 Roche Diagnostics Gmbh (Germany) Preci Control Anti-SARS-CoV-2 9216928190 2020-09-08 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 9 Months Target: IgG (N Protein)
2020-10-26 314994 Quidel Corporation (United States) Sofia SARS Antigen Fia 20374 2020-12-22 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing), Instrument Read Shelf Life: 24 Months Sensitivity: 96.7% (Symptomatic) 91.6% (Serial Asymptomatic)
2020-10-26 314994 Quidel Corporation (United States) Sofia SARS Antigen Fia 20378 2020-12-22 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing), Instrument Read Shelf Life: 24 Months Sensitivity: 96.7% (Symptomatic) 91.6% (Serial Asymptomatic)
2020-05-26 315458 Biofire Diagnostics, Llc. (United States) Biofire Respiratory Panel 2.1 (Rp2.1) 423742 2021-11-09 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 98.0% (Symptomatic)
2020-05-26 315458 Biofire Diagnostics, Llc. (United States) Filmarray Respiratory Panel 2.1 (Rp2.1) 423738 2021-11-29 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 98.0% (Symptomatic)
2020-07-20 315563 Diagnostic Hybrids, Inc. - Also Trading As Quidel Corporation (United States) Lyra Direct SARS-CoV-2 Assay M124 2020-07-20 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 97.0% (Symptomatic)
2020-10-07 315786 Bio-Rad (France) Platelia SARS-CoV-2 Total AB 12013798 2020-10-07 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (N Protein)
2020-10-07 315786 Bio-Rad (France) Platelia SARS-CoV-2 Total AB 72710 2020-10-07 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (N Protein)
2020-06-11 315790 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Calibrator Kit 06R9001 2020-06-11 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 3 Months Target: IgG (N Protein)
2020-06-11 315790 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Control Kit 06R9010 2020-06-11 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 3 Months Target: IgG (N Protein)
2020-06-11 315790 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Reagent Kit 06R9020 2020-06-11 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 3 Months Target: IgG (N Protein)
2020-06-11 315790 Abbott Laboratories Diagnostics Division (United States) SARS-CoV-2 IgG Reagent Kit 06R9030 2020-06-11 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 3 Months Target: IgG (N Protein)
2020-10-26 316823 Diagnostics Biochem Canada Inc. (Canada) Anti-SARS-CoV-2 IgG Elisa Kit CAN-IGG-19 2020-10-26 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein)
2020-10-06 316848 Abbott Molecular Inc. (United States) Alinity M SARS-CoV-2 Amp Kit 09N78-090 2020-10-06 Nucleic Acid Technology Lab-Based Test Np, Op Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 100.0% (Symptomatic)
2020-10-06 316848 Abbott Molecular Inc. (United States) Alinity M SARS-CoV-2 Ctrl Kit 09N78-080 2020-10-06 Nucleic Acid Technology Lab-Based Test Np, Op Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 100.0% (Symptomatic)
2020-08-14 316954 Hologic, Inc. (United States) Aptima Multitest Swab Specimen Collection Kit For SARS-CoV-2 Specimen Collection PRD-03546 2020-08-14 Nucleic Acid Technology Lab-Based Test Nasal, Nasal Wash/Aspirate, Np, Np Wash/Aspirate, Op Symptomatic, Asymptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: >95% (Symptomatic And Asymptomatic, With Sample Pooling)
2020-08-14 316954 Hologic, Inc. (United States) Aptima SARS-CoV-2 Assay Kit PRD-06419 2020-08-14 Nucleic Acid Technology Lab-Based Test Nasal, Nasal Wash/Aspirate, Np, Np Wash/Aspirate, Op Symptomatic, Asymptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: >95% (Symptomatic And Asymptomatic, With Sample Pooling)
2020-08-14 316954 Hologic, Inc. (United States) Aptima SARS-CoV-2 Controls Kit PRD-06420 2020-08-14 Nucleic Acid Technology Lab-Based Test Nasal, Nasal Wash/Aspirate, Np, Np Wash/Aspirate, Op Symptomatic, Asymptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: >95% (Symptomatic And Asymptomatic, With Sample Pooling)
2021-05-07 318801 Artron Laboratories Inc. (Canada) COVID-19 IgM/IgG Antibody Test A03-51-322 2021-05-07 Serological Technology Lab-Based And Point Of Care Test Fingerstick Blood, Venous Whole Blood, Serum, Plasma Instrument Read Shelf Life: 18 Months Target: IgG (S Protein); IgG (N Protein); IgM (S Protein); IgM (N Protein)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Cobas Buffer Negative Control Kit 9051953190 2023-02-13 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 & Influenza A/B 9233474190 2020-11-06 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 & Influenza A/B 9446125190 2023-02-13 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 & Influenza A/B Control Kit 9233482190 2020-11-06 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 & Influenza A/B Control Kit 9446133190 2023-02-13 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Sw Cobas 5800 Scov2-Flua/B Asap Version 1.1.0 9512829001 2023-02-13 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Sw Cobas Scov2-Flua/B Asap 12.1.1 9752315001 2023-02-13 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Sw Cobas Scov2-Flua/B Asap 12.2.0 9579834001 2023-02-13 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Sw Cobas Scov2-Flua/B Asap V 10.1.0 9826041001 2020-11-06 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Sw Cobas Scov2-Flua/B Asap V 11.1.0 9826017001 2020-11-06 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-06 320730 Roche Molecular Systems, Inc (United States) Sw Cobas Scov2-Flua/B Asap V 12.1.0 9826009001 2021-08-10 Nucleic Acid Technology Lab-Based Test Nasal, Np, Op Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 96.4% (Symptomatic)
2020-11-12 321164 Roche Molecular Systems, Inc (United States) Cobas Liat SARS CoV-2 & Influenza A/B Assay Script V1.1 9463526001 2021-08-18 Nucleic Acid Technology Lab-Based And Point Of Care Test Nasal, Np, Supervised Self Collected Nasal Symptomatic Multiplex Instrument Read Shelf Life: 24 Months Sensitivity: 100% (Symptomatic)
2020-11-12 321164 Roche Molecular Systems, Inc (United States) Cobas Liat SARS-CoV-2 & Influenza A/B Quality Control Kit 09211128190 2020-11-12 Nucleic Acid Technology Lab-Based And Point Of Care Test Nasal, Np, Supervised Self Collected Nasal Symptomatic Multiplex Instrument Read Shelf Life: 24 Months Sensitivity: 100% (Symptomatic)
2020-11-12 321164 Roche Molecular Systems, Inc (United States) Cobas Liat SARS-CoV-2 & Influenza A/B Script Software Version 1.0 9260935001 2020-11-12 Nucleic Acid Technology Lab-Based And Point Of Care Test Nasal, Np, Supervised Self Collected Nasal Symptomatic Multiplex Instrument Read Shelf Life: 24 Months Sensitivity: 100% (Symptomatic)
2020-11-12 321164 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 & Influenza A/B 09211101190 2020-11-12 Nucleic Acid Technology Lab-Based And Point Of Care Test Nasal, Np, Supervised Self Collected Nasal Symptomatic Multiplex Instrument Read Shelf Life: 24 Months Sensitivity: 100% (Symptomatic)
2021-02-19 321478 Assure Tech. (Hangzhou) Co. Ltd. (China) COVID-19 Antigen Rapid Test Device COV-S23 2021-02-19 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 93.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-02-19 321478 Assure Tech. (Hangzhou) Co. Ltd. (China) COVID-19 Antigen Rapid Test Device COV-S230045 2021-12-17 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 93.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-02-19 321478 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 Antigen Rapid Test Device COV-S230045E 2022-08-26 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 93.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-02-19 321478 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 Antigen Rapid Test Device COV-S23E 2022-08-26 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 93.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-03-30 321604 Roche Diagnostics Gmbh (Germany) Calset Anti-SARS-CoV-2 S 9289291190 2021-03-30 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein)
2021-03-30 321604 Roche Diagnostics Gmbh (Germany) Elecsys Anti-SARS-CoV-2 S 09289267190 2021-03-30 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein)
2021-03-30 321604 Roche Diagnostics Gmbh (Germany) Elecsys Anti-SARS-CoV-2 S 09289275190 2021-03-30 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein)
2021-03-30 321604 Roche Diagnostics Gmbh (Germany) Precicontrol Anti-SARS-CoV-2 S 9289313190 2021-03-30 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 12 Months Target: IgG (S Protein)
2020-12-18 321634 Cepheid (United States) Xpert Xpress SARS-CoV-2/Flu/RSV XPCOV2/FLU/RSV-10 2020-12-18 Nucleic Acid Technology Point Of Care Test Nasal, Nasal Wash/Aspirate, Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 97.9% (Symptomatic)
2021-02-19 321669 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Device 2070088301 2021-12-03 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 90.2% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-02-19 321669 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Device 2070089201 2021-12-03 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 90.2% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-02-19 321669 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Device BQ001 2022-01-18 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 90.2% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-02-19 321669 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Device COV-19C25 2021-02-19 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 90.2% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-02-19 321669 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Device SWB-19 2021-12-03 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 90.2% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-07-23 321882 Quidel Corporation (United States) Sofia 2 Flu + SARS Antigen Control Set 20391 2021-07-23 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 95.2% (Symptomatic)
2021-07-23 321882 Quidel Corporation (United States) Sofia 2 Flu + SARS Antigen Fia 20377 2021-07-23 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 95.2% (Symptomatic)
2021-07-23 321882 Quidel Corporation (United States) Sofia 2 Flu + SARS Antigen Fia 20380 2021-07-23 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Multiplex, Instrument Read Shelf Life: 24 Months Sensitivity: 95.2% (Symptomatic)
2021-03-03 321941 Euroimmun Medizinische Labordiagnostika Ag (Germany) Eurorealtime SARS-CoV-2 MP 2606-0100 2021-03-03 Nucleic Acid Technology Lab-Based Test Op Symptomatic, Instrument Read Shelf Life: 11 Months Sensitivity: 96.0% (Symptomatic)
2021-03-03 321941 Euroimmun Medizinische Labordiagnostika Ag (Germany) Eurorealtime SARS-CoV-2 MP 2606-0125 2021-03-03 Nucleic Acid Technology Lab-Based Test Op Symptomatic, Instrument Read Shelf Life: 11 Months Sensitivity: 96.0% (Symptomatic)
2021-03-03 321941 Euroimmun Medizinische Labordiagnostika Ag (Germany) Eurorealtime SARS-CoV-2 MP 2606-0200 2021-03-03 Nucleic Acid Technology Lab-Based Test Op Symptomatic, Instrument Read Shelf Life: 11 Months Sensitivity: 96.0% (Symptomatic)
2021-03-03 321941 Euroimmun Medizinische Labordiagnostika Ag (Germany) Eurorealtime SARS-CoV-2 MP 2606-0225 2021-03-03 Nucleic Acid Technology Lab-Based Test Op Symptomatic, Instrument Read Shelf Life: 11 Months Sensitivity: 96.0% (Symptomatic)
2021-03-03 321941 Euroimmun Medizinische Labordiagnostika Ag (Germany) Eurorealtime SARS-CoV-2 MP 2606-0425 2021-03-03 Nucleic Acid Technology Lab-Based Test Op Symptomatic, Instrument Read Shelf Life: 11 Months Sensitivity: 96.0% (Symptomatic)
2021-03-03 321941 Euroimmun Medizinische Labordiagnostika Ag (Germany) Eurorealtime SARS-CoV-2 MP 2606-1000 2021-03-03 Nucleic Acid Technology Lab-Based Test Op Symptomatic, Instrument Read Shelf Life: 11 Months Sensitivity: 96.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Covichek Sample Collection Swab (Nasal Swab) NSA-T3 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Covichek Sample Collection Swab (Nasopharyngeal Swab) NSA-T1 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT001E0 2022-05-20 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT001EN1 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT001EN3 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT002E0 2022-05-20 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT002EN1 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT002EN3 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT005E0 2022-05-20 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT005EN1 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT005EN3 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT010E0 2022-05-20 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT010EN1 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT010EN3 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT025E0 2022-01-21 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT025E1 2022-01-21 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT025EN1 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-21 321979 Sugentech, Inc. (South Korea) Sgti-Flex COVID-19 AG CAGT025EN3 2022-07-13 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.0% (Symptomatic)
2022-01-11 322851 Seegene Inc. (South Korea) Allplex SARS-CoV-2/Flua/Flub/RSV Assay RV10259X 2022-01-11 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 95.2% (Symptomatic)
2022-01-11 322851 Seegene Inc. (South Korea) Allplex SARS-CoV-2/Flua/Flub/RSV Assay RV10349Z 2022-11-02 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 95.2% (Symptomatic)
2022-01-11 322851 Seegene Inc. (South Korea) Seegene Viewer SWSVRCAI01 2022-01-11 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 95.2% (Symptomatic)
2021-09-17 322914 Quidel Corporation (United States) Quickvue SARS Antigen Test 20396 2021-09-17 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 96.6% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-09-17 322914 Quidel Corporation (United States) Quickvue SARS Antigen Test Ctrl Swab Set 20389 2021-09-17 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 96.6% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-04-29 323000 Cue Health Inc. (United States) Cue COVID-19 Test Cartridge Pack C1021-01 2021-07-07 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue COVID-19 Test Cartridge Pack C1021-03 2021-07-07 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue COVID-19 Test Cartridge Pack C1021-05 2023-03-01 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue COVID-19 Test Cartridge Pack C1021-10 2021-07-07 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue COVID-19 Test Cartridge Pack C1021-100 2021-07-07 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue COVID-19 Test External Control Swabs Pack C2113 2021-07-07 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue Health Mobile Application CUE HEALTH APP 2021-04-29 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue Health Monitoring System C0201 2021-04-29 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-04-29 323000 Cue Health Inc. (United States) Cue Wireless Charging Base C0200 2021-04-29 Nucleic Acid Technology Self-Testing And Point Of Care Test Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 92.0% (Symptomatic)
2021-07-02 324498 Diagnostic Hybrids, Inc. - Also Trading As Quidel Corporation (United States) Solana SARS-CoV-2 Assay M312 2022-06-17 Nucleic Acid Technology Lab-Based Test Nasal, Np Symptomatic, Instrument Read Shelf Life: 6 Months Sensitivity: 97.2% (Symptomatic)
2020-12-31 324506 Abbott Rapid Diagnostics Jena Gmbh (Germany) Panbio COVID-19 AGRapid Test Device (Nasal) 41FK11 2020-12-31 Antigen Technology Lab-Based And Point Of Care Test Nasal, Supervised Self Collected Nasal Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 91.1% (Symptomatic)
2020-12-31 324506 Abbott Rapid Diagnostics Jena Gmbh (Germany) Panbio COVID-19 AGRapid Test Device (Nasal) 41FK14 2021-10-27 Antigen Technology Lab-Based And Point Of Care Test Nasal, Supervised Self Collected Nasal Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 91.1% (Symptomatic)
2020-12-31 324506 Abbott Rapid Diagnostics Jena Gmbh (Germany) Panbio COVID-19 AGRapid Test Device (Nasal) 41FK18 2021-10-12 Antigen Technology Lab-Based And Point Of Care Test Nasal, Supervised Self Collected Nasal Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 91.1% (Symptomatic)
2021-09-03 324530 Hologic, Inc. (United States) Aptima SARS-CoV-2/Flu Assay Kit PRD-06815 2021-09-03 Nucleic Acid Technology Lab-Based Test Nasal, Np Symptomatic Multiplex Instrument Read Shelf Life: 12 Months Sensitivity: 96.1% (Symptomatic)
2021-09-03 324530 Hologic, Inc. (United States) Aptima SARS-CoV-2/Flu Controls Kit PRD-06816 2021-09-03 Nucleic Acid Technology Lab-Based Test Nasal, Np Symptomatic Multiplex Instrument Read Shelf Life: 12 Months Sensitivity: 96.1% (Symptomatic)
2021-11-02 324694 Diasorin Inc. (United States) Liaison Control SARS-CoV-2 AG 311501 2022-02-01 Antigen Technology Lab-Based Test Nasal, Np Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 96.1% (Symptomatic)
2021-11-02 324694 Diasorin Inc. (United States) Liaison SARS-CoV-2 AG 311500 2022-02-01 Antigen Technology Lab-Based Test Nasal, Np Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 96.1% (Symptomatic)
2021-11-02 324694 Diasorin Inc. (United States) Liaison SARS-CoV-2 Sample Inactivation Buffer 311502 2022-02-01 Antigen Technology Lab-Based Test Nasal, Np Symptomatic, Instrument Read Shelf Life: 12 Months Sensitivity: 96.1% (Symptomatic)
2021-09-22 324744 Norgen Biotek Corp. (Canada) 2019-NCoV Taqman Rt-PCR Kit Dx DXTM67120 (500RXNS) 2021-09-22 Nucleic Acid Technology Lab-Based Test Np, Op, Saliva Symptomatic, Instrument Read Shelf Life: 6 Months Sensitivity: 100% (Symptomatic)
2021-09-22 324763 Norgen Biotek Corp. (Canada) 2019-NCoV Taqman Rt-PCR Kit Dx DXTM67100 (50RXNS) 2021-09-22 Nucleic Acid Technology Lab-Based Test Np, Op, Saliva Symptomatic, Instrument Read Shelf Life: 6 Months Sensitivity: 100% (Symptomatic)
2021-09-22 324870 Norgen Biotek Corp. (Canada) COVID-19 Taqman Rt-PCR Kit (E/Rdrp Genes) Dx DXTM67200 2021-09-22 Nucleic Acid Technology Lab-Based Test Np, Op, Saliva Symptomatic, Instrument Read Shelf Life: 6 Months Sensitivity: 100% (Symptomatic)
2021-05-10 324977 Ortho-Clinical Diagnostics (Great Britain) Vitros Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator 619 9950 2021-05-10 Antigen Technology Lab-Based Test Np Symptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 95.7% (Symptomatic)
2021-05-10 324977 Ortho-Clinical Diagnostics (Great Britain) Vitros Immunodiagnostic Products SARS-CoV-2 Antigen Controls 619 9943 2021-05-10 Antigen Technology Lab-Based Test Np Symptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 95.7% (Symptomatic)
2021-05-10 324977 Ortho-Clinical Diagnostics (Great Britain) Vitros Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer 619 9944 2021-05-10 Antigen Technology Lab-Based Test Np Symptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 95.7% (Symptomatic)
2021-05-10 324977 Ortho-Clinical Diagnostics (Great Britain) Vitros Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack 619 9949 2021-05-10 Antigen Technology Lab-Based Test Np Symptomatic, Instrument Read Shelf Life: 4 Months Sensitivity: 95.7% (Symptomatic)
2021-06-08 326362 Abbott Molecular Inc. (United States) Alinity M Resp-4-Plex Amp Kit 09N79-090 2021-06-07 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 100% (Symptomatic)
2021-06-08 326362 Abbott Molecular Inc. (United States) Alinity M Resp-4-Plex Ctrl Kit 09N79-080 2021-06-07 Nucleic Acid Technology Lab-Based Test Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 100% (Symptomatic)
2021-09-24 326827 Princeton Biomeditech Corp (United States) Status COVID-19/Flu 33225 2021-09-24 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np, Op Symptomatic, Multiplex, Visual Read Shelf Life: 12 Months Sensitivity: 93.1% (Symptomatic)
2022-02-11 327573 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test L031-11815 2022-02-11 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-02-11 327573 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test L031-125V5 2022-02-25 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-02-11 327573 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test L031-125W5 2022-05-10 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-02-11 327573 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test L031-125Y5 2022-05-10 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-02-11 327573 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test L031-125Z5 2022-05-10 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-02-11 327573 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test L031-129Z5 2022-02-25 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-02-11 327573 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test Control L021-1095 2022-05-10 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-10-20 327866 Artron Laboratories Inc. (Canada) Artron COVID-19 Antigen Test A03-50-422 2021-10-20 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 91.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-10-20 327866 Artron Laboratories Inc. (Canada) Artron COVID-19 Antigen Test (Nasal) A03-50-422PNS1 2021-12-09 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 91.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-10-20 327866 Artron Laboratories Inc. (Canada) Artron COVID-19 Antigen Test (Nasal) A03-50-422PNS25 2021-12-09 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 91.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-10-20 327866 Artron Laboratories Inc. (Canada) Artron COVID-19 Antigen Test (Nasal) A03-50-422PNS5 2021-12-09 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 91.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-10-20 327866 Artron Laboratories Inc. (Canada) Artron COVID-19 Antigen Test (Nasopharyngeal) A03-50-422PNP1 2021-12-09 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 91.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-10-20 327866 Artron Laboratories Inc. (Canada) Artron COVID-19 Antigen Test (Nasopharyngeal) A03-50-422PNP25 2021-12-09 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 91.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-10-20 327866 Artron Laboratories Inc. (Canada) Artron COVID-19 Antigen Test (Nasopharyngeal) A03-50-422PNP5 2021-12-09 Antigen Technology Lab-Based And Point Of Care Test Nasal, Np Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 91.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-06-21 328889 Sd Biosensor, Inc. (South Korea) Standard Q COVID-19 AGNasal Test 09COV37H 2021-09-15 Antigen Technology Lab-Based And Point Of Care Test Nasal, Supervised Self Collected Nasal Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 86.7% (Symptomatic)
2021-06-21 328889 Sd Biosensor, Inc. (South Korea) Standard Q COVID-19 AGNasal Test With Control 09COV36D 2021-09-15 Antigen Technology Lab-Based And Point Of Care Test Nasal, Supervised Self Collected Nasal Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 86.7% (Symptomatic)
2021-04-23 329037 Lucira Health, Inc. (United States) Lucira Checkit COVID-19 Test Kit 8.10E+11 2021-04-23 Nucleic Acid Technology Self-Testing Nasal Symptomatic, Asymptomatic, Instrument Read Shelf Life: 18 Months Sensitivity: 94.0% (Symptomatic) 90.0% (Asymptomatic) 91.7% (Symptomatic And Asymptomatic)
2021-12-09 329453 Abbott Ireland, Diagnostics Division (Ireland) Alinity I Advisedx SARS-CoV-2 IgG Ii Calibrator Kit 06S6101 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-09 329453 Abbott Ireland, Diagnostics Division (Ireland) Alinity I Advisedx SARS-CoV-2 IgG Ii Control Kit 06S6110 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-09 329453 Abbott Ireland, Diagnostics Division (Ireland) Alinity I Advisedx SARS-CoV-2 IgG Ii Reagent Kit 06S6120 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-09 329453 Abbott Ireland, Diagnostics Division (Ireland) Alinity I Advisedx SARS-CoV-2 IgG Ii Reagent Kit 06S6130 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-09 329468 Abbott Ireland, Diagnostics Division (Ireland) Architect Advisedx SARS-CoV-2 IgG Ii Calibrator Kit 6S60-01 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-09 329468 Abbott Ireland, Diagnostics Division (Ireland) Architect Advisedx SARS-CoV-2 IgG Ii Control Kit 6S60-10 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-09 329468 Abbott Ireland, Diagnostics Division (Ireland) Architect Advisedx SARS-CoV-2 IgG Ii Reagent Kit 6S60-20 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-09 329468 Abbott Ireland, Diagnostics Division (Ireland) Architect Advisedx SARS-CoV-2 IgG Ii Reagent Kit 6S60-30 2021-12-09 Serological Technology Lab-Based Test Serum, Plasma Instrument Read Shelf Life: 6 Months Target: IgG (S1 Subunit Of Spike Protein)
2021-12-21 330161 Abbott Rapid Diagnostics Jena Gmbh (Germany) Panbio COVID-19 Antigen Self-Test 41FK501 2022-02-11 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 98.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-12-21 330161 Abbott Rapid Diagnostics Jena Gmbh (Germany) Panbio COVID-19 Antigen Self-Test 41FK701 2022-02-11 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 98.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-12-21 330161 Abbott Rapid Diagnostics Jena Gmbh (Germany) Panbio COVID-19 Antigen Self-Test 41FK801 2022-02-11 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 98.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-12-21 330161 Abbott Rapid Diagnostics Jena Gmbh (Germany) Panbio COVID-19 Antigen Self-Test 41FK901 2022-02-11 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 98.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-04-08 331639 Pcl Inc. (South Korea) Pcl COVID19 AGGold COV04S-1T 2022-04-08 Antigen Technology Point Of Care Test Nasal, Np, Saliva Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.5% (Symptomatic)
2022-04-08 331639 Pcl Inc. (South Korea) Pcl COVID19 AGGold COV04S-50T 2022-04-08 Antigen Technology Point Of Care Test Nasal, Np, Saliva Symptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 88.5% (Symptomatic)
2021-08-26 331681 Quidel Corporation (United States) Quickvue At-Home Otc COVID-19 Test 20410 2021-09-17 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 81.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-08-26 331681 Quidel Corporation (United States) Quickvue At-Home Otc COVID-19 Test 20411 2021-09-17 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 81.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-08-26 331681 Quidel Corporation (United States) Quickvue At-Home Otc COVID-19 Test 20436 2021-12-24 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 81.3% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-02-24 331938 Becton Dickinson And Company (Bd) (United States) Bd Veritor System For Rapid Detection Of SARS-CoV-2 & Flu A+B 256088 2022-02-24 Antigen Technology Point Of Care Test Nasal Symptomatic Multiplex Shelf Life: 16 Months Sensitivity: 86.7%
2022-01-19 333538 Diasorin Molecular Llc (United States) Simplexa COVID-19 & Flu A/B Direct MOL4250 2022-01-19 Nucleic Acid Technology Lab-Based Test Nasal, Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 96.5% (Symptomatic)
2022-01-19 333538 Diasorin Molecular Llc (United States) Simplexa COVID-19 & Flu A/B Positive Control Pack MOL4260 2022-01-19 Nucleic Acid Technology Lab-Based Test Nasal, Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 96.5% (Symptomatic)
2022-03-15 333668 Roche Molecular Systems, Inc (United States) Cobas Liat SARS-CoV-2 Script Version 1.0.1 9425047001 2022-03-15 Nucleic Acid Technology Point Of Care Test Np, Supervised Self Collected Nasal Symptomatic, Asymptomatic Instrument Read. Shelf-Life: 18 Months Sensitivity: 96.1% (Symptomatic), 100% (Asymptomatic)
2022-03-15 333668 Roche Molecular Systems, Inc (United States) Cobas Liat SARS-CoV-2 Script Version 1.0.2 9459545001 2022-03-15 Nucleic Acid Technology Point Of Care Test Np, Supervised Self Collected Nasal Symptomatic, Asymptomatic Instrument Read. Shelf-Life: 18 Months Sensitivity: 96.1% (Symptomatic), 100% (Asymptomatic)
2022-03-15 333668 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 9408592190 2022-03-15 Nucleic Acid Technology Point Of Care Test Np, Supervised Self Collected Nasal Symptomatic, Asymptomatic Instrument Read. Shelf-Life: 18 Months Sensitivity: 96.1% (Symptomatic), 100% (Asymptomatic)
2022-03-15 333668 Roche Molecular Systems, Inc (United States) Cobas SARS-CoV-2 Quality Control Kit 9408835190 2022-03-15 Nucleic Acid Technology Point Of Care Test Np, Supervised Self Collected Nasal Symptomatic, Asymptomatic Instrument Read. Shelf-Life: 18 Months Sensitivity: 96.1% (Symptomatic), 100% (Asymptomatic)
2021-12-10 333956 Sd Biosensor, Inc. (South Korea) SARS-CoV-2 Antigen Self Test Nasal 99COV130J-ML04 2022-04-14 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 94.4% (Symptomatic And Asymptomatic)
2022-04-08 334727 Abbott Diagnostics Scarborough, Inc. (United States) COVID-19 Swab Transport Tube Accessory Pack 190-010 2022-04-08 Nucleic Acid Technology Lab- Based And Point Of Care Test Nasal, Np Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 93.3% (Symptomatic)
2022-04-08 334727 Abbott Diagnostics Scarborough, Inc. (United States) Id Now COVID-19 2.0 193-000C 2022-08-30 Nucleic Acid Technology Lab- Based And Point Of Care Test Nasal, Np Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 93.3% (Symptomatic)
2022-04-08 334727 Abbott Diagnostics Scarborough, Inc. (United States) Id Now COVID-19 2.0 Control Swab Kit 192-080 2022-04-08 Nucleic Acid Technology Lab- Based And Point Of Care Test Nasal, Np Symptomatic, Instrument Read Shelf Life: 24 Months Sensitivity: 93.3% (Symptomatic)
2021-12-23 334992 Orasure Technologies, Inc. (United States) Inteliswab COVID-19 Rapid Test Pro 1001-0614.001 2021-12-23 Antigen Technology Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing) Visual Read Shelf Life: 18 Months Sensitivity: 85.0% (Symptomatic)
2021-12-23 334992 Orasure Technologies, Inc. (United States) Inteliswab COVID-19 Rapid Test Pro Kit Controls 1001-0623 2021-12-23 Antigen Technology Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing) Visual Read Shelf Life: 18 Months Sensitivity: 85.0% (Symptomatic)
2021-12-23 334992 Orasure Technologies, Inc. (United States) Inteliswab COVID-19 Rapid Test Pro Visual Reference Panel 1001-0624 2021-12-23 Antigen Technology Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing) Visual Read Shelf Life: 18 Months Sensitivity: 85.0% (Symptomatic)
2021-12-15 335021 Orasure Technologies, Inc. (United States) Inteliswab COVID-19 Rapid Test 1001-0616.001 2021-12-15 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 9 Months Sensitivity: 85.0% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2021-12-15 335021 Orasure Technologies, Inc. (United States) Inteliswab COVID-19 Rapid Test 1001-0634.001 2023-12-14 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 9 Months Sensitivity: 85.0% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-01-19 336118 Cepheid (United States) Xpert®Xpress CoV-2/Flu/RSV Plus XP3COV2/FLU/RSV-10 2022-01-19 Nucleic Acid Technology Lab-Based Test And Point Of Care Nasal, Nasal Wash/Aspirate, Np Symptomatic, Multiplex, Instrument Read Shelf Life: 12 Months Sensitivity: 100% (Symptomatic)
2022-12-22 339926 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Self-Test Kit COV-19CHC1 2022-12-22 Antigen Technology Self-Testing Shelf Life: 24 Months Sample: Nasal Sensitivity: 92.78%
2022-12-22 339926 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Self-Test Kit COV-19CHC2 2022-12-22 Antigen Technology Self-Testing Shelf Life: 24 Months Sample: Nasal Sensitivity: 92.78%
2022-12-22 339926 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Self-Test Kit COV-19CHC25 2022-12-22 Antigen Technology Self-Testing Shelf Life: 24 Months Sample: Nasal Sensitivity: 92.78%
2022-12-22 339926 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Self-Test Kit COV-19CHC5 2022-12-22 Antigen Technology Self-Testing Shelf Life: 24 Months Sample: Nasal Sensitivity: 92.78%
2023-08-24 341465 Guangzhou Wondfo Biotech Co., Ltd. (China) Wondfo 2019-NCoV Antigen Test (Lateral Flow Method) W196P0031 2023-08-23 Antigen Technology Point Of Care Test Nasal Symptomatic Visual Read Shelf Life: 18 Months Sensitivity: 85.5%
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-1T-NS 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-1T-S 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-25T-NS 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-25T-S 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-2T-NS 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-2T-S 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-3T-NS 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-3T-S 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-50T-NS 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-50T-S 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-5T-NS 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-05-05 341676 Pcl Inc. (South Korea) Pcl Self Test - COVID 19 AG COV04ST-5T-S 2023-05-25 Antigen Technology Self-Testing Saliva Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 90.14% (Sensitivity Has Not Been Established For Serial Testing) Shelf-Life: 24 Months
2022-06-03 342114 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) L031-118L5 2022-06-03 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 94.12% (Sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-Life: 24 Months
2022-06-03 342114 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) L031-118M5 2022-06-03 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 94.12% (Sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-Life: 24 Months
2022-06-03 342114 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) L031-118P5 2022-06-03 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 94.12% (Sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-Life: 24 Months
2022-06-03 342114 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) L031-118R5 2022-06-03 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 94.12% (Sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-Life: 24 Months
2022-06-03 342114 Acon Biotech (Hangzhou) Co., Ltd. (China) Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) L031-118Z5 2022-06-03 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 94.12% (Sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-Life: 24 Months
2022-12-19 342359 Beijing Hotgen Biotech Co.,Ltd. (China) Coronavirus (2019-NCoV)-Antigentest- HGCG134S0101 2022-12-19 Antigen Technology Self-Testing Shelf Life: 18 Months Sample: Anterior Nasal Sensitivity: 80.9%
2022-12-19 342359 Beijing Hotgen Biotech Co.,Ltd. (China) Coronavirus (2019-NCoV)-Antigentest- HGCG134S0102 2022-12-19 Antigen Technology Self-Testing Shelf Life: 18 Months Sample: Anterior Nasal Sensitivity: 80.9%
2022-12-19 342359 Beijing Hotgen Biotech Co.,Ltd. (China) Coronavirus (2019-NCoV)-Antigentest- HGCG134S0105 2022-12-19 Antigen Technology Self-Testing Shelf Life: 18 Months Sample: Anterior Nasal Sensitivity: 80.9%
2022-12-19 342359 Beijing Hotgen Biotech Co.,Ltd. (China) Coronavirus (2019-NCoV)-Antigentest- HGCG134S0120 2022-12-19 Antigen Technology Self-Testing Shelf Life: 18 Months Sample: Anterior Nasal Sensitivity: 80.9%
2022-12-19 342359 Beijing Hotgen Biotech Co.,Ltd. (China) Coronavirus (2019-NCoV)-Antigentest- HGCG134S0140 2022-12-19 Antigen Technology Self-Testing Shelf Life: 18 Months Sample: Anterior Nasal Sensitivity: 80.9%
2022-05-19 342369 Sd Biosensor, Inc. (South Korea) Standard I-Q COVID-19 AGHome Test 09COV120H 2022-05-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 87.8% (Symptomatic And Asymptomatic)
2022-05-19 342369 Sd Biosensor, Inc. (South Korea) Standard I-Q COVID-19 AGHome Test 09COV120J 2022-05-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 87.8% (Symptomatic And Asymptomatic)
2022-03-04 342731 Biolytical Laboratories Inc. (Canada) Istatis COVID-19 Antigen Test 90-1114 2022-03-04 Antigen Technology Point Of Care Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 14 Months Sensitivity: 91.43% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-03-04 342731 Biolytical Laboratories Inc. (Canada) Istatis COVID-19 Antigen Test 90-1125 2022-07-06 Antigen Technology Point Of Care Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 14 Months Sensitivity: 91.43% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-03-04 342928 Btnx Inc. (Canada) COVID-19 Antigen Controls COV-CS06 2022-03-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Shelf-Life: 24 Months Sensitivity: 94.51%
2022-03-04 342928 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Cassette - At Home COV-19CSHC1 2022-03-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Shelf-Life: 24 Months Sensitivity: 94.51%
2022-03-04 342928 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Cassette - At Home COV-19CSHC2 2022-03-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Shelf-Life: 24 Months Sensitivity: 94.51%
2022-03-04 342928 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Cassette - At Home COV-19CSHC25 2022-03-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Shelf-Life: 24 Months Sensitivity: 94.51%
2022-03-04 342928 Btnx Inc. (Canada) Rapid Response COVID-19 Antigen Rapid Test Cassette - At Home COV-19CSHC5 2022-03-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Shelf-Life: 24 Months Sensitivity: 94.51%
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000+ 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000C1 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000C1+ 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000C40 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000C40+ 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000C5 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-28 342960 Andon Medical Co., Ltd. (China) Ihealth COVID-19 Antigen Rapid Test ICO-3000C5+ 2022-04-28 Antigen Technology Self-Testing Symptomatic, Asymptomatic (Serial Testing) Shelf-Life: 13 Months Sample: Nasal Sensitivity: Symptomatic (85-94.3%); Serial Testing (Clinical Sensitivity To Be Established)
2022-04-01 343050 Healgen Scientific Limited Liability Company (United States) Clinitest Rapid COVID-19 Antigen Self-Test GCCOV-502A-H1US (11561922) 2022-04-06 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 11 Months Sensitivity: 86.5% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-04-01 343050 Healgen Scientific Limited Liability Company (United States) Clinitest Rapid COVID-19 Antigen Self-Test GCCOV-502A-H1US (11561923) 2022-04-06 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 11 Months Sensitivity: 86.5% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-04-01 343050 Healgen Scientific Limited Liability Company (United States) Clinitest Rapid COVID-19 Antigen Self-Test GCCOV-502A-H5US (11561920) 2022-04-01 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 11 Months Sensitivity: 86.5% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-04-01 343050 Healgen Scientific Limited Liability Company (United States) Clinitest Rapid COVID-19 Antigen Self-Test GCCOV-502A-H5US (11561921) 2022-04-06 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 11 Months Sensitivity: 86.5% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-08-04 343139 Access Bio, Inc. (United States) Carestarttm COVID-19 Antigen Home Test RCPM-00173 2022-08-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 12 Months Sensitivity: 86.67% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-08-04 343139 Access Bio, Inc. (United States) Carestarttm COVID-19 Antigen Home Test RCPM-00273 2022-08-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 12 Months Sensitivity: 86.67% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-08-04 343139 Access Bio, Inc. (United States) Carestarttm COVID-19 Antigen Home Test RCPM-00473 2022-08-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 12 Months Sensitivity: 86.67% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-08-04 343139 Access Bio, Inc. (United States) Carestarttm COVID-19 Antigen Home Test RCPM-02073 2022-08-04 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 12 Months Sensitivity: 86.67% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-07-22 343356 Humasis Co., Ltd, (South Korea) Humasis COVID-19 AGHome Test ACOVGS-7002 2022-07-22 Antigen Technology Self-Testing Mid-Turbinate Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 86.7% (Symptomatic And Asymptomatic, Sensitivity Has Not Been Established For Serial Testing)) Shelf Life: 18 Months
2022-07-22 343356 Humasis Co., Ltd, (South Korea) Humasis COVID-19 AGHome Test ACOVGS-7005 2022-07-22 Antigen Technology Self-Testing Mid-Turbinate Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 86.7% (Symptomatic And Asymptomatic, Sensitivity Has Not Been Established For Serial Testing)) Shelf Life: 18 Months
2022-07-22 343356 Humasis Co., Ltd, (South Korea) Humasis COVID-19 AGHome Test ACOVGS-7025 2022-07-22 Antigen Technology Self-Testing Mid-Turbinate Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 86.7% (Symptomatic And Asymptomatic, Sensitivity Has Not Been Established For Serial Testing)) Shelf Life: 18 Months
2022-03-29 344136 Medsup Medical (Canada) Medsup COVID-19 Rapid Antigen Test MS-TRA-5 2022-03-29 Antigen Technology Lab-Based And Point Of Care Test Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 24 Months Sensitivity: 97.1% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2023-06-12 344305 Hangzhou Alltest Biotech Co., Ltd. (China) SARS-CoV-2 Antigen Control SCSCO-S 2023-06-12 Antigen Technology Point Of Care Test Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 19 Months Sensitivity: 95.5%
2023-06-12 344305 Hangzhou Alltest Biotech Co., Ltd. (China) SARS-CoV-2 Antigen Rapid Test INCP-G502 2023-06-12 Antigen Technology Point Of Care Test Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 19 Months Sensitivity: 95.5%
2022-04-01 344422 Biolytical Laboratories Inc. (Canada) Istatis COVID-19 Antigen Home Test 90-1119 2022-04-01 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 14 Months Sensitivity: 85.37% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-04-01 344422 Biolytical Laboratories Inc. (Canada) Istatis COVID-19 Antigen Home Test 90-1121 2022-04-01 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 14 Months Sensitivity: 85.37% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-04-01 344422 Biolytical Laboratories Inc. (Canada) Istatis COVID-19 Antigen Home Test 90-1130 2022-10-03 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 14 Months Sensitivity: 85.37% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-04-01 344422 Biolytical Laboratories Inc. (Canada) Istatis COVID-19 Antigen Home Test 90-1133 2023-01-06 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Shelf Life: 14 Months Sensitivity: 85.37% (Symptomatic); Sensitivity Has Not Been Established For Serial Testing
2022-07-19 345281 Acon Laboratories, Inc. (United States) Flowflex COVID-19 Antigen Home Test L031-126H5 2022-07-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic, Visual Read Sensitivity = 93% Shelf-Life = 24 Months
2022-07-19 345281 Acon Laboratories, Inc. (United States) Flowflex COVID-19 Antigen Home Test L031-126J5 2022-07-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic, Visual Read Sensitivity = 93% Shelf-Life = 24 Months
2022-07-19 345281 Acon Laboratories, Inc. (United States) Flowflex COVID-19 Antigen Home Test L031-126K5 2022-07-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic, Visual Read Sensitivity = 93% Shelf-Life = 24 Months
2022-07-19 345281 Acon Laboratories, Inc. (United States) Flowflex COVID-19 Antigen Home Test L031-126L5 2022-07-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic, Visual Read Sensitivity = 93% Shelf-Life = 24 Months
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-1-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-10-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-2-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-20-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-4-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-40-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-5-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-05-27 346090 Xiamen Boson Biotech Co., Ltd. (China) Rapid SARS-CoV-2 Antigen Test Card (For Self-Testing) 1N40C5-8-CA 2022-05-27 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-07-29 347175 Acon Laboratories, Inc. (United States) Flowflex COVID-19 Antigen Rapid Test L031-13015 2022-07-29 Antigen Technology Point Of Care Test Nasal,

Symptomatic, Asymptomatic, Visual Read Shelf Life: 24 Months Sensitivity: 93% (Symptomatic, Asymptomatic)
2022-07-07 347652 Lucira Health, Inc. (United States) Lucira COVID-19 & Flu Test LUC-13000-CA 2022-07-07 Nucleic Acid Technology Self-Testing And Point Of Care Test Symptomatic Multiplex, Instrument Read Shelf Life: 18 Months Nasal Swabs Sensitivity: 98.2%
2023-06-13 348023 Phase Scientific International (China) Indicaid (Tm) COVID-19 Rapid Antigen At-Home Test P0092 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 12 Months Sensitivity: 81.7%
2023-06-13 348023 Phase Scientific International (China) Indicaid (Tm) COVID-19 Rapid Antigen At-Home Test P0093 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 12 Months Sensitivity: 81.7%
2023-06-13 348023 Phase Scientific International (China) Indicaid (Tm) COVID-19 Rapid Antigen At-Home Test P0094 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 12 Months Sensitivity: 81.7%
2023-06-13 348023 Phase Scientific International (China) Indicaid (Tm) COVID-19 Rapid Antigen At-Home Test P0095 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 12 Months Sensitivity: 81.7%
2022-10-26 348386 Response Biomedical Corporation (Canada) Ramp COVID-19 Antigen Test C1120-100 2022-10-26 Antigen Technology Lab-Based Test Nasal Symptomatic Instrument Read Shelf-Life = 24 Month Sensitivity = 84%
2022-10-26 348386 Response Biomedical Corporation (Canada) Ramp COVID-19 Antigen Test C1120-25 2022-10-26 Antigen Technology Lab-Based Test Nasal Symptomatic Instrument Read Shelf-Life = 24 Month Sensitivity = 84%
2022-10-26 348386 Response Biomedical Corporation (Canada) Ramp COVID-19 Antigen Test Control Swabs C2020 2022-10-26 Antigen Technology Lab-Based Test Nasal Symptomatic Instrument Read Shelf-Life = 24 Month Sensitivity = 84%
2022-08-09 348414 Gene Biotechnology Enterprises Ltd (Canada) Swiftswab COVID-19 Antigen Self Test COV-19NS1 2022-08-09 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-08-09 348414 Gene Biotechnology Enterprises Ltd (Canada) Swiftswab COVID-19 Antigen Self Test COV-19NS2 2022-08-09 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-08-09 348414 Gene Biotechnology Enterprises Ltd (Canada) Swiftswab COVID-19 Antigen Self Test COV-19NS4 2022-08-09 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-08-09 348414 Gene Biotechnology Enterprises Ltd (Canada) Swiftswab COVID-19 Antigen Self Test COV-19NS5 2022-08-09 Antigen Technology Self-Testing Pop: Serial Testing Symptomatic And Asymptomatic Shelf Life: 18 Months Sample: Nasal Sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (Clinical Sensitivity To Be Established)
2022-12-19 349022 Cepheid (United States) Xpert Xpress CoV-2 Plus XP3SARS-COV2-10 2022-12-16 Nucleic Acid Technology Lab-Based And Point Of Care Test Shelf Life: 12 Months Sample: Np, Nasal, Op And Nasal Wash/Aspirate Sensitivity: 100% (Symptomatic) And 100% (Asymptomatic)
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Disposable Sterile Swab B2 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Disposable Swabs CF 075-P 3B 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 Antigen Home Test COV-S23010H10E 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 Antigen Home Test COV-S23010H1E 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 Antigen Home Test COV-S23010H20E 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 Antigen Home Test COV-S23010H2E 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 Antigen Home Test COV-S23010H5E 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 Antigen Home Test COV-S23010H10F 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 Antigen Home Test COV-S23010H1F 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 Antigen Home Test COV-S23010H20F 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 Antigen Home Test COV-S23010H2F 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 Antigen Home Test COV-S23010H5F 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-10-18 349698 Assure Tech. (Hangzhou) Co. Ltd. (China) Sterile Medical Sampler CJS-6 2023-10-18 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93.6%
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Disposable Sterile Swabs B1 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 & Influenza A/B Antigen Combo Test Device MI-S4300110E 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 & Influenza A/B Antigen Combo Test Device MI-S4300120E 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Ecotest COVID-19 & Influenza A/B Antigen Combo Test Device MI-S430015E 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 & Influenza A/B Antigen Combo Test Device MI-S4300110F 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 & Influenza A/B Antigen Combo Test Device MI-S4300120F 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Fastep COVID-19 & Influenza A/B Antigen Combo Test Device MI-S430015F 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Nasopharyngeal Swab CF 150-P2C 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Negative Control MI-C01 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-11-08 349747 Assure Tech. (Hangzhou) Co. Ltd. (China) Positive Control MI-C02 2023-11-08 Antigen Technology Point Of Care Test Np, Nasal Symptomatic Multiplex Visual Read Shelf Life: 24 Months Sensitivity: 95.0% (Np), 94.0% (Nasal)
2023-01-20 350132 Artron Laboratories Inc. (Canada) COVID-19 Antigen Home Test A03-50-422S1 2023-01-20 Antigen Technology Self-Testing Pop. = Symptomatic And Asymptomatic (Serial Testing) Visual Read Shelf-Life = 24 Months Sample = Nasal Sensitivity = 100.0%
2023-01-20 350132 Artron Laboratories Inc. (Canada) COVID-19 Antigen Home Test A03-50-422S25 2023-01-20 Antigen Technology Self-Testing Pop. = Symptomatic And Asymptomatic (Serial Testing) Visual Read Shelf-Life = 24 Months Sample = Nasal Sensitivity = 100.0%
2023-01-20 350132 Artron Laboratories Inc. (Canada) COVID-19 Antigen Home Test A03-50-422S5 2023-01-20 Antigen Technology Self-Testing Pop. = Symptomatic And Asymptomatic (Serial Testing) Visual Read Shelf-Life = 24 Months Sample = Nasal Sensitivity = 100.0%
2022-08-19 350168 Medsup Medical (Canada) Medsup COVID-19 Antigen Rapid Test (Self-Testing) MS-TRA-SD-1 2022-08-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 94.12% (Sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-Life: 24 Months
2022-08-19 350168 Medsup Medical (Canada) Medsup COVID-19 Antigen Rapid Test (Self-Testing) MS-TRA-SD-5 2022-08-19 Antigen Technology Self-Testing Nasal Symptomatic, Asymptomatic (Serial Testing), Visual Read Sensitivity: 94.12% (Sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-Life: 24 Months
2023-06-12 350748 Hangzhou Alltest Biotech Co., Ltd. (China) Allchek COVID-19 Antigen Home Test INCP-G502H01 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 91.4%
2023-06-12 350748 Hangzhou Alltest Biotech Co., Ltd. (China) Allchek COVID-19 Antigen Home Test INCP-G502H02 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 91.4%
2023-06-12 350748 Hangzhou Alltest Biotech Co., Ltd. (China) Allchek COVID-19 Antigen Home Test INCP-G502H05 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 91.4%
2023-06-12 350748 Hangzhou Alltest Biotech Co., Ltd. (China) Allchek COVID-19 Antigen Home Test INCP-G502H07 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 91.4%
2023-06-12 350748 Hangzhou Alltest Biotech Co., Ltd. (China) Allchek COVID-19 Antigen Home Test INCP-G502H10 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 91.4%
2023-06-12 350748 Hangzhou Alltest Biotech Co., Ltd. (China) Allchek COVID-19 Antigen Home Test INCP-G502H20 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 91.4%
2023-06-12 350748 Hangzhou Alltest Biotech Co., Ltd. (China) Allchek COVID-19 Antigen Home Test INCP-G502H25 2023-06-12 Antigen Technology Self-Testing Nasal Symptomatic And Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 91.4%
2022-11-01 350927 Becton Dickinson And Company (Bd) (United States) Bd Respiratory Viral Panel For Bd Maxtm System 445215 2022-11-01 Nucleic Acid Technology Lab-Based Test Shelf Life: 18 Months Multiplex Sample: Nasal, Np Sensitivity: SARS-CoV-2: 98%
2023-06-02 356389 Btnx Inc. (Canada) Negative Control COF-C01 2023-06-01 Antigen Technology Lab-Based And Point Of Care Test Np, Nasal Symptomatic Visual Read Shelf Life: 24 Months Sensitivity: 94.7% (Np), 93.6% (Nasal)
2023-06-02 356389 Btnx Inc. (Canada) Positive Control COF-C02 2023-06-01 Antigen Technology Lab-Based And Point Of Care Test Np, Nasal Symptomatic Visual Read Shelf Life: 24 Months Sensitivity: 94.7% (Np), 93.6% (Nasal)
2023-06-02 356389 Btnx Inc. (Canada) Rapid Response Influenza AB+COVID-19 Antigen -3 In 1 Test COF-19CPC25 2023-06-01 Antigen Technology Lab-Based And Point Of Care Test Np, Nasal Symptomatic Visual Read Shelf Life: 24 Months Sensitivity: 94.7% (Np), 93.6% (Nasal)
2023-06-02 356389 Btnx Inc. (Canada) Rapid Response Influenza AB+COVID-19 Antigen -3 In 1 Test COF-19CPC5 2023-06-01 Antigen Technology Lab-Based And Point Of Care Test Np, Nasal Symptomatic Visual Read Shelf Life: 24 Months Sensitivity: 94.7% (Np), 93.6% (Nasal)

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