Testing devices for use against coronavirus (COVID-19): List of authorized devices

Only testing devices authorized by Health Canada can be imported or sold in Canada. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. Health Canada has confirmed that authorized COVID-19 tests are well supported by evidence indicating they will provide accurate and reliable results.

This page is updated daily Monday to Friday. Last updated on May 29, 2020

Health care professionals can request access to COVID-19 medical devices not yet approved for sale in Canada through the Medical Devices Special Access Program.

For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.

The following testing devices have been authorized for sale or import in Canada under the interim order:

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
Liaison Sars-Cov-2 S1/S2 IgG, Liaison Control Sars-Cov-2 S1/S2 IgG Diasorin Inc.
(United States)
Serological technology Lab-based test 2020-05-12
1copy COVID-19 QPCR Kit 1DROP INC. (imported by Luminarie Canada Inc.)
(South Korea)
Nucleic acid technology Lab-based test 2020-03-30
Abbott Realtime SARS-COV-2 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 Life Sciences Research Institute (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 2020-04-06
Qiastat-DX Respiratory SARS-CoV-2 Panel Qiagen Gmbh (Germany) Nucleic acid technology Lab-based test 2020-05-27
SARS-CoV-2 Assay (Panther Fusion System) Hologic (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-CoV-2 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 technology Lab-based test 2020-05-14
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