Testing devices for COVID-19: List of applications under evaluation

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 confirms 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 October 26, 2020.

If you recently learned that a device is under evaluation, please allow at least 48 hours for this list to be updated. We are receiving an extremely high volume of requests for authorization. We are unable to prioritize requests for status updates at this time.

COVID-19 Diagnostic Device Applications Received by Health Canada
Device name Manufacturer Device typeFootnote 1 Laboratory or Point of Care TestFootnote 1 Status
Alinity I Advisedx Sars-Cov-2 Igm Assay Abbott Ireland, Diagnostics Division (Ireland) Serological (antibody) technology Lab-based test Under Review
Kantaro Quantitative Sars-Cov-2 Igg Antibody Kit Kantaro Biosciences, Llc (United States) Serological (antibody) technology Lab-based test Under Review
Architect Advisedx Sars-Cov-2 Igm Assay Abbott Ireland, Diagnostics Division (Ireland) Serological Technology Lab-based test Under Review
Kaira 2019-Ncov Detection Kit Optolane Technologies, Inc. (South Korea) Nucleic Acid Technology Lab-based test Under Review
Novel Coronavirus (Covid-19) Nucleic Acid Detection Kit (Fluorescent Pcr) Wareton And Company Technology Co. Limited (China) Nucleic Acid Technology Lab-based test Under Review
Covid-19 Antigen Rapid Test Device Assure Tech. (Hangzhou) Co. Ltd. (China) Antigen Technology Lab-based and Point of care test Under Review
Covid 19 Sero Speed-Igm-Igg Biospeedia S.A.S. (France) Serological (antibody) technology Lab-based and Point of care test Under Review
Elecsys Anti-Sars-Cov-2 S Roche Diagnostics Gmbh (Germany) Serological (antibody) technology Lab-based test Under Review
Rapid Response Covid-19 Antigen Rapid Test Device Btnx Inc. (Canada) Antigen Technology Lab-based and Point of care test Under Review
Biocredit Covid-19 Ag Rapigen Inc. (South Korea) Antigen Technology Point of care test Under Review
Pathogendx Detect X-Rv Pathogendx (United States) Nucleic Acid Technology Lab-based test Under Review
Dimension Exl Sars-Cov-2 Igg (Cv2g) Siemens Healthcare Diagnostics Inc. (United States) Serological (antibody) technology Lab-based test Under review
Anti-SARS-Cov-2 IgM Elisa Kit Diagnostics Biochem Canada Inc. (Canada) Serological (antibody) technology Lab-based test Under review
Lyher 2019-Ncov Igm/Igg Antibody Test Kit, One Step Rapid Test Device Hangzhou Laihe Biotech Co., Ltd (China) Serological (antibody) technology Lab-based test Under review
Novel Coronavirus (2019-Ncov) RT-PCR Detection Kit Shanghai Fosun Long March Medical Science Co., Ltd (China) Nucleic acid technology Lab-based test Under Review
2019-NCOV IgG/IgM Diagnostic Kit (Colloidal Gold) Nanjing Vazyme Medical Technology Co. Ltd (China) Serological (antibody) technology Point of care test Under Review
2019-nCoV IgG/IgM Rapid Test Cassette Hangzhou Alltest Biotech Co., Ltd. (China) Serological (antibody) technology Lab-based test Under Review
Covid-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) Zhengzhou Fortune Bioscience Co. Ltd. (China) Serological (antibody) technology Point of care test Under Review
COVID-19 Igm/IgG Antibody Test Artron Laboratories Inc. (Canada) Serological (antibody) technology Point of care test Under review
COVID-19 Nucleic Acid Detection Kit (Fluorescence PCR) Esenso Biotech Inc. (Canada) Nucleic Acid Technology Lab-based test Under Review
Covid-19 IgG/IgM Rapid Test Device Assure Tech. (Hangzhou) Co. Ltd. (China) Serological (antibody) technology Point of care test Under Review
Liferiver Novel Coronavirus (Sars-Cov-2) Real-Time Multiplex RT-PCR Kit Shanghai ZJ Bio-Tech Co., Ltd (China) Nucleic Acid Technology Lab-based test Under review
NADAL®COVID-19 IgG/IgM Test Nal Von Minden GmbH. (imported by Luminarie Canada Inc.) (Germany) Serological (antibody) technology Point of care test Under review
SARS-CoV-2 Antibody Test (Colloidal Gold Immunochromatography) Lepu Medical Technology (China) Serological (antibody) technology Point of care test Under Review
Neoplex Covid-19 Detection Kit Genematrix Inc. (South Korea) Nucleic Acid Technology Lab-based test Under Review
Dimension Vista SARS-Cov-2 Total Antibody (Cov2t) Siemens Healthcare Diagnostics Inc. Serological (antibody) technology Lab-based test Under Review
Sgti-Flex Covid-19 Ag Sugentech, Inc. (South Korea) Antigen Technology Lab-based and Point of care test Under Review
Eurorealtime Sars-Cov-2 Euroimmun Medizinische Labordiagnostika Ag (Germany) Nucleic Acid Technology Lab-Based Test Under Review
Standard Q COVID-19 AG Test SD Biosensor, Inc. (Korea) Antigen Technology Point of care test Awaiting response from manufacture
Standard Q COVID-19 IgM/IgG Duo Test SD Biosensor, Inc. (Korea) Serological (antibody) technology Point of care test Under Review
Vitros Immunodiagnostic Products Anti-SARS-COV-2 IgG- Reagent Pack, Calibrator And Control Ortho-Clinical Diagnostics (United Kingdom) Serological (antibody) technology Lab-based test Under Review
Wondfo SARS-COV-2 Antibody Test (Lateral Flow Method) Guangzhou Wondfo Biotech Co., Ltd. (China) Serological (antibody) technology Lab-based test Under Review
Sona Nanotech Covid-19 Lateral Flow Assay Sona Nanotech Inc. (Canada) Antigen Technology Point of care test Under Review
Sars-Cov-2 Igm/Igg Detection Kit (Colloidal Gold-Based) Immunodiagnostics Ltd (Hong Kong) Serological (antibody) technology Lab-based test Under Review
Sars-Cov-2 Np Igg Elisa Kit Immunodiagnostics (Shenzhen) Biotech Limited (China) Serological (antibody) technology Lab-based test Under Review
The Covid-19 Igg/Igm Antibody Rapid Test Kit (Colloidal Gold Immune-Chromatography) Vanstar Biotek Co., Ltd. (Canada) Serological (antibody) technology Point of care test Under Review
Covid-19 (Sars-Cov-2) Igm/Igg Antibody Test Kit (Colloidal Gold) Anhui Deepblue Medical Technology., Ltd (China) Serological (antibody) technology Lab-based test Under Review
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescence Quantitative RT-PCR) Higene Nucleic Acid Technology Lab-based test Under Review
Pathodetect COVID-19 Qualitative PCR Kit Mylab Discovery Solutions (India) Nucleic Acid Technology Lab-based test Under Review
Viasure SARS-CoV-2 Real Time PCR Detection Kit Certest Biotec S.L. (Spain) Nucleic Acid Technology Lab-based test Under review
Genomecov19 Detection Kit Applied Biological Materials Inc. (Canada) Nucleic Acid Technology Lab-based test Under review
One Step Test For Novel Coronavirus (2019-Ncov) IgM/IgG Antibody (Colloidal Gold) Getein Biotech Inc. (China) Serological (antibody) technology Lab-based test Under Review
Rapid Response CoVid-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) BTNX Inc. (Canada) Serological (antibody) technology Lab-based test Under Review
Covid-19 Igg/Igm Rapid Test Cassette Cth Controls Inc. (Turkey) Serological (antibody) technology Lab-based test Awaiting response from manufacturer
Sars-Covid-2 Igm/Igg Antibody Test Kit (Colloidal Gold-Method) Biohit Healthcare (Hefei) Co., Ltd. (China) Serological (antibody) technology Lab-based test Under review
SARS-CoV-2 IgG/IgM Rapid Qualitative Test Xiamen Biotime Biotechnology Co., Ltd (China) Serological (antibody) technology Point of care test Under review
(Covid-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay), Dry Fluorescence Immunoassay Analyzer (Portable) Lansion Biotechnology Co., Ltd. (China) Serological (antibody) technology Lab-based test Under Review
EDI Novel Coronavirus Covid-19 IgG And IgM Elisa Kits Epitope Diagnostics Inc. (United States) Serological (antibody) technology Lab-based test Under Review
Diagnovital Coronavirus (2019-NCoV) Detection Kit RTA Laboratories (Turkey) Nucleic acid technology Lab-based test Under Review
Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Sansure Biotech Inc. (China) Nucleic acid technology Lab-based test Under Review
Smart Detect SARS-Cov-2 rRT-PCR Kit Inbios International Inc. (United States) Nucleic Acid Technology Lab-based test Under Review
Tell Me Fast Coronavirus (Covid-19) IgG/IgM Antibody Test Biocan Diagnostics Inc. (Canada) Serological (antibody) technology Lab-based test Under review
Covid-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Hangzhou Biotest Biotech Co. Ltd. (China) Serological (antibody) technology Lab-based test Under Review
Covid-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Healgen Scientific Limited Liability Company Serological (antibody) technology Point of care test Under review
Ilamp Novel-Cov19 Detection Kit Ionebio Co., Ltd. (South Korea) Nucleic Acid Technology Lab-based test Under review
2019-Novel Coronavirus (2019-Ncov) Triplex RT-QPCR Detection Kit Nanjing Vazyme Medical Technology Co. Ltd (China) Nucleic Acid Technology Lab-based test Under Review
Triplelock SARS-Cov-2 Test Strips Precision Biomonitoring Inc. (Canada) Nucleic Acid Technology Lab-based test Awaiting response from manufacturer
Paxview Covid-19 Real-Time RT-PCR Kit Paxgenbio Co., Ltd (Korea) Nucleic Acid Technology Lab-based test Under Review
Palm PCR CoVid-19 Fast Real-Time RT-PCR Kit Ahram Biosystems Inc. (South Korea) Nucleic Acid technology Point of care test Under Review
Discovid Covid-19 IgM/IgG Antibody Test Kit (Colloidal Gold) Antagen Pharmaceuticals, Inc. (United States) Serological (antibody) technology Lab-based test Under review
U-Top Covid-19 Detection Kit Seasun Biomaterials Inc. (South Korea) Nucleic Acid Technology Lab-based test Under Review
Diagnostic Kit (Colloidal Gold) For IgG/IgM Antibody to SARS-Cov-2 Xiamen Wiz Biotech Co., Ltd. (China) Serological (antibody) technology Lab-based test Under Review
Isopollo Covid-19 Detection Kit (Real-Time) M Monitor Inc. (South Korea) Nucleic Acid Technology Lab-based test Under review
Allplex SARS-Cov-2 Assay Seegene Inc. (South Korea) Nucleic Acid Technology Lab-based test Under review
Anti-SARS-Cov-2 IgG Elisa Kit Diagnostics Biochem Canada Inc. (Canada) Serological (antibody) technology Lab-based test Under review
GB SARS-Cov-2 Real-Time RT-PCR (Catalog No. 4pco002e) General Biologicals Corporation (Taiwan) Nucleic Acid Technology Lab-based test Under review
2019-Ncov (Orf1ab/E/N) Fluorescent PCR (Nucleic Acid Test Kit) Maccura Biotechnology Co., Ltd. (China) Nucleic Acid Technology Lab-based test Under review
Covid-19 IgM Antibody Rapid Test Kit Hecin Scientific, Inc. (China) Serological (antibody) technology Lab-based test Under Review
Acco Rapid Test, Covid-19 IgM/IgG Accobiotech Sdn. Bhd. (Malaysia) Serological (antibody) technology Lab-based test Under Review
Hymon SARS-Cov-2 Test Kit Hymonbio Co., Ltd. (China) Nucleic Acid Technology Lab-based test Under Review
SCOV Immune Response Test DLS Research And Ventures Serological (antibody) technology Lab-based test Under Review
Novel Coronavirus (2019-Ncov) IgG/IgM Test Kit (Colloidal Gold) Genrui Biotech Serological (antibody) technology Lab-based test Under review
Covid-19 IgG/IgM Rapid Test Kit Wuhan Unscience Biotechnology Co., Ltd. (China) Serological (antibody) technology Lab-based test Under review
Ichroma COVID-19 Ab Boditech Med Inc. (Korea) Serological (antibody) technology Lab-based test Awaiting response from manufacturer
Anti-Sars-CoV-2 IgA Elisa Kit Diagnostics Biochem Canada Inc. (Canada) Serological (antibody) technology Lab-based test Under Review
Access Sars-Cov-2 Igg Reagent Pack Access Sars-Cov-2 Igg Calibrator Access Sars-Cov-2 Igg Qc Beckman Coulter, Inc. (United States) Serological (antibody) technology Lab-based test Under Review
Dimension Exl Sars-Cov-2 Total Antibody (Cv2t) Siemens Healthcare Diagnostics Inc. (United States) Serological (antibody) technology Lab-based test Under review
Accupower Sars-Cov-2 Real-Time Rt-Pcr Kit Bioneer Co. Ltd (Korea) Nucleic Acid Technology Lab-based test Awaiting response from manufacturer
Real-Time Covid-19 Gencurix Inc. (Korea) Nucleic Acid Technology Lab-based test Under review
Acu-Corona 2.0 Acumen Diagnostics Pte Ltd. (Singapore) Nucleic Acid Technology Lab-based test Under Review
Anti-Sars-Cov-2 Total Antibody (Ab) Elisa Kit Diagnostics Biochem Canada Inc. (Canada) Serological (antibody) technology Lab-based test Under review
Genesig Real-Time PCR Coronavirus (COVID-19) CE IVD Kit Primerdesign Ltd (United Kingdom) Nucleic Acid Technology Lab-based test Awaiting response from manufacture
Cpass Sars-Cov-2 Neutralization Antibody Detection Kit Genscript Usa, Inc. (United States) Neutralization Antibody Technology Lab-based test Under Review
Sofia 2 Sars Antigen Fia Diagnostic Hybrids, Inc. - also trading as Quidel Corporation (United States) Antigen Technology Lab-based test / Point of care test Under Review
Id Screen Sars-Cov-2-N Igg Indirect Idvet (France) Serological (antibody) technology Lab-based test Under Review
Quantivirus Sars-Cov-2 Multiplex Test Kit Diacarta Inc.(United States) Nucleic Acid Technology Lab-based test Under Review
Zekmed Covid-19 Total Igg / Igm Rapid Test Cassette (Whole Blood / Serum / Plasma) Zenum Sarl (Switzerland) Serological (antibody) technology Lab-based test Under Review
Onsite Covid-19 Igg/Igm Rapid Test Ctk Biotech, Inc. (United States) Serological (antibody) technology Lab-based test Under Review
Novel Coronavirus (2019-Ncov) Real-Time Pcr Kit Long Island Biotech, Inc. (United States) Nucleic Acid Technology Lab-based test Under Review
Protect Covid-19 Rt-Qpcr Kit Jn Medsys (Singapore) Nucleic Acid Technology Lab-based test Awaiting response from manufacturer
Standard M-Ncov Real-Time Detection Kit Sd Biosensor, Inc. (Korea) Nucleic Acid Technology Lab-based test Under Review
Sars-Cov-2 Panel Agena Bioscience Inc, (United States) Nucleic Acid Technology Lab-based test Awaiting response from manufacturer
Veri-Q Covid-19 Multiplex Detection Kit Micobiomed Co., Ltd. (South Korea) Nucleic Acid Technology Lab-based test Under Review
Frend System / Frend Covid-19 Igg/Igm Duo Nanoentek, Inc. (Korean) Serological (antibody) technology Lab-based and Point of care test Under Review
Covid-19 Igg / Igm Rapid Test Device Sensing Self Pte. Ltd. (Singapore) Serological (antibody) technology Lab-based test Under Review
Covid-19 Igm Antibody Test Kit Guangdong Hecin Scientific, Inc. (China) Serological (antibody) technology Lab-based test Under Review
Cobas Sars-Cov-2 & Influenza A/B Roche Molecular Systems, Inc (United States) Nucleic Acid Technology Lab-based test Under Review
Cobas Liat Sars-Cov-2 & Influenza A/B Roche Molecular Systems, Inc (United States) Nucleic Acid Technology Lab-based and Point of care test Under Review
Genecount Covid-19 Rt-Qpcr Assay Kit Luminultra Technologies Ltd. (Canada) Nucleic acid technology Lab-based test Under Review
Vivadiag Covid-19 Igm/Igg Rapid Test Vivachek Biotech (Hangzhou) Co., Ltd. (China) Serological (antibody) technology Lab-based test Under Review
Advia Centaur Sars-Cov-2 IGG Siemens Healthcare Diagnostics Inc. (United States) Serological (antibody) technology Lab-based test Under Review
Covid-19 Igg/Igm Rapid Test Kit Nantong Egens Biotechnology Co., Ltd. (China) Serological (antibody) technology Lab-based test Awaiting response from manufacturer
Atellica Im Sars-Cov-2 Igg (Cov2g), Atellica Im Sars-Cov-2 Igg Quality Control (Cov2g Qc) Siemens Healthcare Diagnostics Inc. (United States) Serological (antibody) technology Lab-based test Under Review
Table 1 Footnote 1

Lab-based means the technology must be used in a laboratory. Point of Care means the technology can be used in doctors offices, for example.

Return to footnote 1 referrer

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