Quidel Sofia antigen approved yesterdayIt was approved yesterday the 26th of October 2020 as per HC but updated today. If Quidel's test has been approved we can be certain that Sona's will be approved soon! To be fair Quidel applied before Sona and it was in line for approval. Here is the list of approved devices :
COVID-19 Testing Device Applications Authorized by Health CanadaDevice NameManufacturerDevice TypeLaboratory or Point of Care Test
Table 1 - Footnote1Date Authorized1copy COVID-19 QPCR Multi Kit1DROP INC. (imported by Luminarie Canada Inc.)
(South Korea)Nucleic acid technologyLab-based test2020-03-30Abbott Realtime SARS-COV-2 AssayAbbott Molecular Inc.
(United States)Nucleic acid TechnologyLab-based test2020-03-25Advia Centaur Sars-Cov-2 Total (Cov2t) / Advia Centaur Sars-Siemens Healthcare Diagnostics Inc. (Unites States)Serological (antibody) technologyLab-based test2020-08-14Alinity M Sars-Cov-2 Amp Kit, Alinity M Sars-Cov-2 Ctrl KitAbbott Molecular Inc. (United States)Nucleic Acid TechnologyLab-based test2020-10-06Allplex 2019-NCoV AssaySeegene Inc.
(Korea)Nucleic Acid TechnologyLab-based test2020-04-09Anti-SARS-CoV-2 Elisa (IgG)Euroimmun Medizinische Labordiagnostika Ag (Germany)Serological (antibody) technologyLab-based test2020-09-25Anti-SARS-Cov-2 IgG Elisa KitDiagnostics Biochem Canada Inc. (Canada)Serological (antibody) technologyLab-based test2020-10-26Aptima Sars-Cov-2 Assay Kit And Controls Kit, Aptima Multitest Swab Specimen Collection Kit For Sars-Cov-2 Specimen CollectionHologic, Inc. (United States)Nucleic Acid TechnologyLab-based test2020-08-14Aries SARS-CoV-2 AssayLuminex Corporation (United States)Nucleic acid technologyLab-based test2020-06-11Atellica Im Sars-Cov-2 Total (Cov2t) / Atellica Im Sars-Cov2- Total Quality Control (Cov2t Qc)Siemens Healthcare Diagnostics Inc.Serological (antibody) technologyLab-based test2020-08-14BD SARS-CoV-2 Reagents For BD Max SystemBecton Dickinson and Company (Canada)Nucleic acid technologyLab-based test2020-04-19Bd Veritor System For Rapid Detection Of Sars-Cov-2Becton Dickinson And Company (Bd) (United States)Antigen TechnologyLab-based test and Point of care test2020-10-09Biofire COVID - 19 Test & Biofire COVID - 19 External Control Test Kit (+)
Table 1 - Footnote2Biofire Defense LLC (United States)Nucleic Acid TechnologyLab-based test2020-05-04Biofire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC. (United States)Nucleic acid technologyLab-based test2020-05-26Biomeme SARS-COV-2 TestBiomeme Inc. (United States)Nucleic acid technologyLab-based test2020-06-30BKit Virus Finder Covid-19Hyris Ltd. (United Kingdom)Nucleic Acid technologyPoint of care test2020-09-23cobas SARS-CoV-2Roche (United States)Nucleic acid technologyLab-based testInitial authorization - 2020-03-18
Amended authorization 2020-04-09DiaPlexQ Novel Coronavirus (2019-nCoV) Detection KitSolgent Co., Ltd.
(South Korea)Nucleic acid technologyLab-based test2020-04-05DiaSorin Simplexa COVID-19 Direct Molecular Assay on the LIAISON MDX InstrumentDiaSorin Molecular LLC
(United States)Nucleic Acid technologyLab-based test2020-04-09Dimension Exl Sars-Cov-2 Total Antibody (Cv2t)Siemens Healthcare Diagnostics Inc.(United States)Serological (antibody) technologyLab-based test2020-09-08Dimension Vista Sars-Cov-2 Total Antibody (Cov2t)Siemens Healthcare Diagnostics Inc.(United States)Serological (antibody) technologyLab-based test2020-09-08Elecsys Anti-SARS-CoV-2Roche Diagnostics Gmbh (Germany)Serological (antibody) technologyLab-based test2020-06-05FTD SARS-COV-2Fast Track Diagnostics Luxembourg S.A.R.L. (Luxembourg)Nucleic acid technologyLab-based test2020-07-23Genefinder CoVid-19 Plus Realamp KitOsang Healthcare Co., Ltd. (South Korea)Nucleic Acid technologyLab-based test2020-04-21ID NOW COVID19Abbott Diagnostics Scarborough Inc. (United States)Nucleic Acid TechnologyLab-based test and point of care test2020-09-30Liaison SARS-Cov-2 S1/S2 IgGDiasorin Inc.
(United States)Serological (antibody) technologyLab-based test2020-05-12Lyra Direct Sars-Cov-2 AssayDiagnostic Hybrids, Inc. - Also Trading as Quidel Corporation
(United States)Nucleic acid technologyLab-based test2020-07-21LYRA SARS-COV-2 ASSAYDiagnostic Hybrids, Inc. - Also trading as Quidel Corporation (United States)Nucleic acid technologyLab-based test2020-03-25NxTAG COV Extended PanelLuminex Molecular Diagnostics, Inc.
(Canada)Nucleic acid technologyLab-based test2020-03-26Panbio Covid-19 Ag Rapid Test Device (Nasopharyngeal)Abbott Rapid Diagnostics (Germany)Antigen TechnologyLab-based test and Point of care test2020-10-05Panther Fusion System - SARS-CoV-2 AssayHologic, Inc. (United States)Nucleic acid technologyLab-based test2020-03-25PerkinElmer New Coronavirus Nucleic Acid Detection KitPerkinElmer, Inc. (United States)Nucleic Acid TechnologyLab-based test2020-04-07Platelia SARS-CoV-2 Total AbBio-Rad (France)Serological (antibody) technologyLab-based test2020-10-07Qiastat-DX Respiratory SARS-CoV-2 PanelQiagen Gmbh (Germany)Nucleic acid technologyLab-based test2020-05-27Real-time Fluorescent RT-PCR Kit For Detecting SARS-2019-nCoVBGI Americas Corp. (China)Nucleic Acid TechnologyLab-based test2020-05-04SARS-CoV-2 IgG AssayAbbott Laboratories, Diagnostics Division (United States)Serological (antibody) technologyLab-based test2020-05-14SARS-CoV-2 IgG Assay (Alinity I)Abbott Laboratories Diagnostics Division (United States)Serological (antibody) technologyLab-based test2020-06-11Sars-Cov-2 Virus Detection Diagnostic Kit (Rt-Qpcr Method)Ningbo Health Gene Technologies Co., Ltd (China)Nucleic Acid TechnologyLab-based test2020-08-10Sofia 2 Sars Antigen FiaDiagnostic Hybrids, Inc. - also trading as Quidel Corporation (United States)Antigen TechnologyLab-based test / Point of care test2020-10-26Spartan Cube COVID-19 SystemSpartan Bioscience Inc. (Canada)Nucleic acid technologyPoint of care testResearch Use Only
2020-05-02TaqPathTM COVID-19 Combo KitThermo Fisher (United States)Nucleic acid technologyLab-based test2020-03-18Vitros Immunodiagnostic Products Anti-Sars-Cov-2 Total Reagent Pack, Vitros Immunodiagnostic Products Anti-Sars-Cov-2 Total CalibratorOrtho-Clinical Diagnostics Inc.
(United States)Serological (antibody) technologyLab-based test2020-06-08Xpert Xpress SARS-CoV-2Cepheid (United States)Nucleic a
eturn to Table 1 - Footnote