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 July 31 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
Anti-SARS-Cov-2 IgM Elisa Kit Diagnostics Biochem Canada Inc. (Canada) Serological 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 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 technology Point of care test Under Review
2019-nCoV IgG/IgM Rapid Test Cassette Hangzhou Alltest Biotech Co., Ltd. (China) Serological technology Lab-based test Under
Review
Advia Centaur SARS-COV-2 Total (COV2T) / Advia Centaur SARS-COV -2 Total Quality Control (COV2T QC) Siemens Healthcare Diagnostics Inc. (United States) Serological technology Lab-based test Under review
Covid-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) Zhengzhou Fortune Bioscience Co. Ltd. (China) Serological technology Point of care test Under Review
COVID-19 IgG/IgM Rapid Test Device Safecare Biotech (Hangzhou) Co. Ltd. (China) Serological Technology Point of care test Under Review
COVID-19 Igm/IgG Antibody Test Artron Laboratories Inc. (Canada) Serological 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 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
Lilif COVID-19 Real-Time RT-PCR Kit Intron Biotechnology (South Korea) Nucleic Acid Technology Lab-based test Awaiting response from manufacturer
2019-NCOV Direct QPCR Kit Healgen Scientific Limited Liability Company (United States) 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 technology Point of care test Awaiting response from manufacturer
SARS-CoV-2 Antibody Test (Colloidal Gold Immunochromatography) Lepu Medical Technology (China) Serological technology Point of care test Under Review
SARS-COV-2 Virus Detection Diagnostic Kit (RT-QPCR Method) Ningbo Health Gene Technologies Co., Ltd (China) Nucleic acid technology Lab-based 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 technology Lab-based test Under review
Standard Q COVID-19 AG Test SD Biosensor, Inc. (Korea) Serological Technology Point of care test Under Review
Standard Q COVID-19 IgM/IgG Duo Test SD Biosensor, Inc. (Korea) Serological 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 technology Lab-based test Under Review
Wondfo SARS-COV-2 Antibody Test (Lateral Flow Method) Guangzhou Wondfo Biotech Co., Ltd. (China) Serological Technology Lab-based test Under Review
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescence Quantitative RT-PCR) Julix (Hong Kong) Company Limited (China) 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 Technology Lab-based test Under Review
Platelia SARS-COV-2 Total Antibody Bio-Rad (France) Serological technology Lab-based test Under Review
Rapid Response CoVid-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) BTNX Inc. (Canada) Serological technology Lab-based test Under Review
Anti-SARS-CoV-2 Elisa (IgG) Euroimmun Medizinische Labordiagnostika Ag (Germany) Serological technology Lab-based test Under Review
Anti-SARS-CoV-2 Elisa (IgA) Euroimmun Medizinische Labordiagnostika Ag (Germany) Serological technology Lab-based test Under Review
SARS-CoV-2 IgG/IgM Rapid Qualitative Test Xiamen Biotime Biotechnology Co., Ltd (China) Serological 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 technology Lab-based test Under Review
Logix Smart Coronavirus Disease 2019 (COVID-19) Co-Diagnostics Inc. (United States) Nucleic acid technology Lab-based test Under Review
EDI Novel Coronavirus Covid-19 IgG And IgM Elisa Kits Epitope Diagnostics Inc. (United States) Serological 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 Awaiting response from manufacturer
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 technology Lab-based test Under review
QSARS-Cov-2 IgG/IgM Rapid Test Cellex, Inc. (United States) Serological technology Lab-based test Under review
Covid-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Hangzhou Biotest Biotech Co. Ltd. (China) Serological technology Lab-based test Under review
BKit Virus Finder Covid-19 Hyris Ltd. (United Kingdom) Nucleic Acid technology Lab-based test Awaiting response from manufacturer
Rida Gene SARS-Cov-2 R-Biopharm AG (Germany) Nucleic Acid Technology Lab-based test Under review
Covid-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Healgen Scientific Limited Liability Company Serological technology Point of care test Under review
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 Under Review
Novel Coronavirus (Covid-19) IgM Antibody Rapid Test Kit Qingdao Hightop Biotech Co. Ltd. (China) Serological technology Lab-based 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 Under review
Paxview Covid-19 Real-Time RT-PCR Kit Paxgenbio Co., Ltd (Korea) Nucleic Acid Technology Lab-based test Under review
Pathogendx Detect X-Rv Pathogendx (United States) 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 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
Covid-2019 Virus Nucleic Acid Detection Kit (Dual-RT-PCR) Guangzhou Deaou Biotechnology Co., Ltd. (China) 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 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 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 technology Lab-based test Under review
Acco Rapid Test, Covid-19 IgM/IgG Accobiotech Sdn. Bhd. (Malaysia) Serological technology Lab-based test Under review
Hymon SARS-Cov-2 Test Kit Hymonbio Co., Ltd. (China) Nucleic Acid Technology Lab-based test Under review
Real-Q 2019-Ncov Detection Kit Biosewoom, Inc. Nucleic Acid 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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