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 22, 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.

Table 1: COVID-19 Testing Device Applications Authorized by Health Canada
Device Name Manufacturer Device Type Laboratory or Point of Care TestTable 1 - Footnote 1 Date Authorized
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 Go-Strips for use with Biomeme's Franklin Real-Time PCR System 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
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