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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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2882 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Attana AB Commercial: Attana AVA SARS-CoV-2 IgG Immunoassay Device ID: 2335 Method: Immunoassay Target: Antibody, IgG Format: Automated, Lab-based, Semi-automated Go to details
CE Marking: No Manufacturer: Attomarker Ltd. Commercial: Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP Device ID: 44 Method: Immunoassay Target: Antibody, IgA Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Aura Biotechnologies Ltd. Commercial: Quick COVID-19 Colorimetric LAMP PCR Device ID: 516 Method: LAMP Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Aura Biotechnologies Ltd. Commercial: Quick COVID-19 Realtime Multiplex PCR Device ID: 517 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Aurora Biomed Inc. Commercial: SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation Device ID: 45 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: AusDiagnostics Commercial: SARS-CoV-2, Influenza and RSV 8-well Device ID: 46 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Autobio Diagnostics Co. Ltd. Commercial: Anti-SARS-CoV-2 Rapid Test Device ID: 665 Method: Immunoassay Target: Antibody, IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Autobio Diagnostics Co. Ltd. Commercial: SARS-CoV-2 IgG II CLIA Microparticles Device ID: 919 Method: CLIA Target: Antibody, IgG Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. Commercial: Anti-SARS-CoV-2 RBD CLIA Microparticles Device ID: 2429 Method: CLIA Target: Antibody Format: Automated Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. Commercial: Anti-SARS-CoV-2 RBD ELISA Device ID: 2430 Method: ELISA Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. Commercial: SARS-CoV-2 Ag Rapid Test Device ID: 2538 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. Commercial: SARS-CoV-2 Ag Rapid Test (self-test) Device ID: 3082 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. Commercial: SARS-CoV-2 NAb ELISA Device ID: 2431 Method: ELISA Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: Avacta Life Sciences Ltd. Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test Device ID: 2426 Method: Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: AVALUN SAS Commercial: Ksmart® SARS-COV2 Antigen Rapid Test Device ID: 1800 Method: Immunochromatography Target: Antigen Format: Semi-automated Go to details
CE Marking: No Manufacturer: Avellino Lab Commercial: Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) Device ID: 48 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Avioq Bio-Tech Co. Ltd. Commercial: Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold) Device ID: 47 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Avioq Bio-Tech Co. Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold) Device ID: 1972 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH Commercial: COVID-19 Antigen Rapid Test Card Device ID: 2101 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH Commercial: COVID-19 Antigen Saliva Test Device ID: 2476 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Axium Bioresearch Inc. Commercial: AxiumHealth COVID-19 IgG/IgM Antibody Test Device ID: 775 Method: Immunoassay Target: Antibody Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc. Commercial: COVID-19 Antigen Rapid Test Device Device ID: 1906 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc. Commercial: COVID-19 Antigen Saliva Test Kit Device ID: 1911 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc. Commercial: COVID-19 IgG/IgM Rapid Test Device Device ID: 1912 Method: Immunoassay Target: Antibody, IgG, IgM Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc. Commercial: COVID-19 Neutralizing Antibody FIA Device ID: 1910 Method: Immunoassay Target: Antibody Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc. Commercial: Dia Sure COVID-19 Antigen Rapid Test Device Device ID: 2060 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc. Commercial: Dia Sure COVID-19 Antigen Rapid Test Device Device ID: 2382 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Ä°DÄ°L BÄ°OTECH ARAÅžTIRMA SAN. VE TÄ°C. Ltd. ÅžTÄ°. Commercial: RevoDx SARS-CoV-2 qPCR Kit Device ID: 2877 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: B-bio Co. Ltd. Commercial: ChekR™ COVID-19 IgM/IgG Rapid test Device ID: 1613 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: B-bio Co. Ltd. Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test Device ID: 1615 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BAG Diagnostics Commercial: Viro-Q SARS-CoV-2 kit Device ID: 703 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Baicare(Tianjin) Biotechnology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Device ID: 2602 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: Baicare(Tianjin) Biotechnology Co. Ltd. Commercial: SARS-CoV-2 Real Time RT-PCR Kit Device ID: 2738 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Baiya Phytopharm Co. Ltd. Commercial: Baiya Rapid COVID-19 IgM/IgG test kit Device ID: 50 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Bako Diagnostics Commercial: BakoDx SARS-CoV-2 RNA test Device ID: 704 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Bakter Medical s.r.o. Commercial: Saligen Device ID: 1782 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Bao Ruiyuan Biotech (Beijing) Co. Ltd. Commercial: Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR Device ID: 51 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: BBB Inc. Commercial: MARK-B COVID-19 Ag Device ID: 2315 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BBB Inc. Obelis S.A.(BE) Commercial: MARK-B COVID-19 Ag S Device ID: 1234 Method: Immunoassay Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Beckman Coulter Commercial: ACCESS SARS-CoV-2 IgG Device ID: 2996 Method: CLIA Target: IgG Format: Automated Go to details
CE Marking: Yes Manufacturer: Beckman Coulter Commercial: ACCESS SARS-CoV-2 IgG (1st IS) Device ID: 2994 Method: CLIA Target: IgG Format: Automated Go to details
CE Marking: Yes Manufacturer: Beckman Coulter Commercial: ACCESS SARS-CoV-2 IgG II Device ID: 2995 Method: CLIA Target: IgG Format: Automated Go to details
CE Marking: Yes Manufacturer: Beckman Coulter Commercial: ACCESS SARS-CoV-2 IgM Device ID: 2997 Method: CLIA Target: IgM Format: Automated Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD Kit For Rapid Detection of SARS-CoV-2 Device ID: 2282 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD SARS-CoV-2 Reagents for BD MAX System Device ID: 706 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD SARS-CoV-2/Flu for BD Max Systems Device ID: 2883 Method: RT-PCR Target: Nucleic acid Format: Automated Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD Veritor™ System for Rapid Detection of SARS CoV 2 Device ID: 1065 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Becton Dickinson Commercial: BioGX SARS-CoV-2 Reagents for BD MAX System Device ID: 518 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing Abace Biology Co. Ltd. Commercial: COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) Device ID: 1281 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Abace Biology Co. Ltd. Commercial: COVID-19 Viral Antigen Test Kit (ELISA) Device ID: 1282 Method: ELISA Target: Antigen Format: Automated, Manual Go to details

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements