Authorized medical devices for uses related to COVID-19: List of authorized testing devices
This page is updated daily Monday to Friday. Last updated on October 30, 2020.
If you recently learned that a device was authorized, please allow at least 48 hours for this list to be updated. Health Canada is receiving an extremely high volume of requests for authorization. We are unable to prioritize requests for status updates at this time.
We have authorized the following testing devices for sale or import in Canada through the interim order for importing and selling medical devices.
| Device Name | Manufacturer | Device Type | Laboratory or Point of Care TestTable 1 - Footnote 1 | Date Authorized |
|---|---|---|---|---|
| Sofia 2 Sars Antigen Fia | Diagnostic Hybrids, Inc. - also trading as Quidel Corporation (United States) | Antigen Technology | Lab-based test / Point of care test | 2020-10-26 |
| Anti-SARS-Cov-2 IgG Elisa Kit | Diagnostics Biochem Canada Inc. (Canada) | Serological (antibody) technology | Lab-based test | 2020-10-26 |
| Bd Veritor System For Rapid Detection Of Sars-Cov-2 | Becton Dickinson And Company (Bd) (United States) | Antigen Technology | Lab-based test and Point of care test | 2020-10-09 |
| Alinity M Sars-Cov-2 Amp Kit, Alinity M Sars-Cov-2 Ctrl Kit | Abbott Molecular Inc. (United States) | Nucleic Acid Technology | Lab-based test | 2020-10-06 |
| Panbio Covid-19 Ag Rapid Test Device (Nasopharyngeal) | Abbott Rapid Diagnostics (Germany) | Antigen Technology | Lab-based test and Point of care test | 2020-10-05 |
| ID NOW COVID19 | Abbott Diagnostics Scarborough Inc. (United States) | Nucleic Acid Technology | Lab-based test and point of care test | 2020-09-30 |
| Anti-SARS-CoV-2 Elisa (IgG) | Euroimmun Medizinische Labordiagnostika Ag (Germany) | Serological (antibody) technology | Lab-based test | 2020-09-25 |
| FTD SARS-COV-2 | Fast Track Diagnostics Luxembourg S.A.R.L. (Luxembourg) | Nucleic acid technology | Lab-based test | 2020-07-23 |
| Lyra Direct Sars-Cov-2 Assay | Diagnostic Hybrids, Inc. - Also Trading as Quidel Corporation (United States) |
Nucleic acid technology | Lab-based test | 2020-07-21 |
| Vitros Immunodiagnostic Products Anti-Sars-Cov-2 Total Reagent Pack, Vitros Immunodiagnostic Products Anti-Sars-Cov-2 Total Calibrator | Ortho-Clinical Diagnostics Inc. (United States) |
Serological (antibody) technology | Lab-based test | 2020-06-08 |
| Liaison SARS-Cov-2 S1/S2 IgG | Diasorin Inc. (United States) |
Serological (antibody) technology | Lab-based test | 2020-05-12 |
| 1copy COVID-19 QPCR Multi Kit | 1DROP INC. (imported by Luminarie Canada Inc.) (South Korea) |
Nucleic acid technology | Lab-based test | 2020-03-30 |
| Abbott Realtime SARS-COV-2 Assay | Abbott Molecular Inc. (United States) |
Nucleic acid Technology | Lab-based test | 2020-03-25 |
| Allplex 2019-NCoV Assay | Seegene Inc. (Korea) |
Nucleic Acid Technology | Lab-based test | 2020-04-09 |
| Biofire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC. (United States) | Nucleic acid technology | Lab-based test | 2020-05-26 |
| cobas SARS-CoV-2 | Roche (United States) | Nucleic acid technology | Lab-based test | Initial authorization - 2020-03-18 Amended authorization 2020-04-09 |
| DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | Solgent Co., Ltd. (South Korea) |
Nucleic acid technology | Lab-based test | 2020-04-05 |
| DiaSorin Simplexa COVID-19 Direct Molecular Assay on the LIAISON MDX Instrument | DiaSorin Molecular LLC (United States) |
Nucleic Acid technology | Lab-based test | 2020-04-09 |
| Genefinder CoVid-19 Plus Realamp Kit | Osang Healthcare Co., Ltd. (South Korea) | Nucleic Acid technology | Lab-based test | 2020-04-21 |
| LYRA SARS-COV-2 ASSAY | Diagnostic Hybrids, Inc. - Also trading as Quidel Corporation (United States) | Nucleic acid technology | Lab-based test | 2020-03-25 |
| NxTAG COV Extended Panel | Luminex Molecular Diagnostics, Inc. (Canada) |
Nucleic acid technology | Lab-based test | 2020-03-26 |
| PerkinElmer New Coronavirus Nucleic Acid Detection Kit | PerkinElmer, Inc. (United States) | Nucleic Acid Technology | Lab-based test | 2020-04-07 |
| Qiastat-DX Respiratory SARS-CoV-2 Panel | Qiagen Gmbh (Germany) | Nucleic acid technology | Lab-based test | 2020-05-27 |
| Panther Fusion System - SARS-CoV-2 Assay | Hologic, Inc. (United States) | Nucleic acid technology | Lab-based test | 2020-03-25 |
| Spartan Cube COVID-19 System | Spartan Bioscience Inc. (Canada) | Nucleic acid technology | Point of care test | Research Use Only 2020-05-02 |
| TaqPathTM COVID-19 Combo Kit | Thermo Fisher (United States) | Nucleic acid technology | Lab-based test | 2020-03-18 |
| Xpert Xpress SARS-CoV-2 | Cepheid (United States) | Nucleic acid technology | Lab-based test Point of care test |
2020-03-24 |
| BD SARS-CoV-2 Reagents For BD Max System | Becton Dickinson and Company (Canada) | Nucleic acid technology | Lab-based test | 2020-04-19 |
| Real-time Fluorescent RT-PCR Kit For Detecting SARS-2019-nCoV | BGI Americas Corp. (China) | Nucleic Acid Technology | Lab-based test | 2020-05-04 |
| Biofire COVID - 19 Test & Biofire COVID - 19 External Control Test Kit (+)Table 1 - Footnote 2 | Biofire Defense LLC (United States) | Nucleic Acid Technology | Lab-based test | 2020-05-04 |
| SARS-CoV-2 IgG Assay | Abbott Laboratories, Diagnostics Division (United States) | Serological (antibody) technology | Lab-based test | 2020-05-14 |
| Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Gmbh (Germany) | Serological (antibody) technology | Lab-based test | 2020-06-05 |
| Aries SARS-CoV-2 Assay | Luminex Corporation (United States) | Nucleic acid technology | Lab-based test | 2020-06-11 |
| SARS-CoV-2 IgG Assay (Alinity I) | Abbott Laboratories Diagnostics Division (United States) | Serological (antibody) technology | Lab-based test | 2020-06-11 |
| Biomeme SARS-COV-2 Test | Biomeme Inc. (United States) | Nucleic acid technology | Lab-based test | 2020-06-30 |
| Sars-Cov-2 Virus Detection Diagnostic Kit (Rt-Qpcr Method) | Ningbo Health Gene Technologies Co., Ltd (China) | Nucleic Acid Technology | Lab-based test | 2020-08-10 |
| Advia Centaur Sars-Cov-2 Total (Cov2t) / Advia Centaur Sars- | Siemens Healthcare Diagnostics Inc. (Unites States) | Serological (antibody) technology | Lab-based test | 2020-08-14 |
| Aptima Sars-Cov-2 Assay Kit And Controls Kit, Aptima Multitest Swab Specimen Collection Kit For Sars-Cov-2 Specimen Collection | Hologic, Inc. (United States) | Nucleic Acid Technology | Lab-based test | 2020-08-14 |
| Atellica Im Sars-Cov-2 Total (Cov2t) / Atellica Im Sars-Cov2- Total Quality Control (Cov2t Qc) | Siemens Healthcare Diagnostics Inc. | Serological (antibody) technology | Lab-based test | 2020-08-14 |
| Dimension Exl Sars-Cov-2 Total Antibody (Cv2t) | Siemens Healthcare Diagnostics Inc.(United States) | Serological (antibody) technology | Lab-based test | 2020-09-08 |
| Dimension Vista Sars-Cov-2 Total Antibody (Cov2t) | Siemens Healthcare Diagnostics Inc.(United States) | Serological (antibody) technology | Lab-based test | 2020-09-08 |
| BKit Virus Finder Covid-19 | Hyris Ltd. (United Kingdom) | Nucleic Acid technology | Point of care test | 2020-09-23 |
| Platelia SARS-CoV-2 Total Ab | Bio-Rad (France) | Serological (antibody) technology | Lab-based test | 2020-10-07 |
Report a problem or mistake on this page
- Date modified: