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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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2049 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit Device ID: 2280 Method: Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: COVID-19 Antigen Rapid Test Device Device ID: 2270 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: ECOTEST COVID-19 Antigen Nasal Test Kit Device ID: 2277 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: ECOTEST COVID-19 Antigen Rapid Test Device (Nasopharyngeal swab, Oropharyngeal swab) Device ID: 2350 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: FaStep COVID-19 Antigen Nasal Test Kit Device ID: 2469 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: FASTEP COVID-19 Antigen Rapid Test Device Device ID: 2364 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Assut Europe Commercial: Covid-19 IgG/IgM RAPID TEST Device ID: 1036 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ASSUT EUROPE SPA Commercial: COVID-19 N.A.T. Neutralizing Antibodies Test Device ID: 2195 Method: Other Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: ASSUT EUROPE SPA Commercial: SARS-CoV-2 Antigen Rapid Swab Device ID: 2248 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Asterion Otel İnşaat Bilişim Medikal Maden Tic.Ltd.Şti. Commercial: As-check Device ID: 2454 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Link Technology Co., Ltd. Commercial: FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit Device ID: 2937 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Link Technology Co., Ltd. Commercial: NOVA Test® SARS-CoV-2 Antigen Home Test Kit Device ID: 2956 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Link Technology Co., Ltd. Commercial: NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Device ID: 2010 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Medical Commercial: Atlas COVID-19 IgG/IgM Test Cassette Device ID: 515 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Medical Commercial: Atlas COVID-19 IgM Elisa Kit Device ID: 773 Method: ELISA Target: Antibody, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Atlas Medical Commercial: Atlas COVID-19 S1-RBD IgG Elisa Kit Device ID: 772 Method: ELISA Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Atlas Medical Commercial: Atlas COVID-19 Total Antibody Elisa Kit Device ID: 771 Method: ELISA Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Atlas Medical GmbH Commercial: Atlas COVID-19 Antigen (Nasal Swab) Test Cassette Device ID: 2959 Method: Immunoassay Target: Antigen Format: Manual Go to details
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: 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: AUTOBIO DIAGNOSTICS., LTD. Commercial: SARS-CoV-2 NAb Q CLIA Microparticles Device ID: 2232 Method: CLIA Target: Antibody Format: Automated 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: 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: 2382 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: 2060 Method: Immunochromatography Target: Antigen Format: Near POC / POC 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: 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: 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: 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: 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

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