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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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305 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S. Commercial: SMARAPIDTEST Device ID: 1344 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: A. Menarini Diagnostics Commercial: ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB) Device ID: 1608 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Abionic SA Commercial: IVD CAPSULE COVID-19-NP Device ID: 2975 Method: Immunoassay Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Abioteq GmbH Commercial: Cora Gentest-19 Device ID: 2374 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: FIAflex SARS-CoV-2 Antigen FIA Device ID: 1669 Method: Immunoassay Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ACON Laboratories Inc. Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) Device ID: 1908 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc. Commercial: COVID-19 Antigen Rapid Test Device ID: 1688 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc. Commercial: COVID-19 Antigen Rapid Test (For Reader) Device ID: 1702 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc. Commercial: COVID-19 Antigen Rapid Test (Oral Fluid) Device ID: 1949 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc. Commercial: COVID-19 Antigen Test Cassette (For Analyzer) Device ID: 1700 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc. Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Device ID: 2267 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AESKU.DIAGNOSTICS GmbH & Co. KG Commercial: AESKU.RAPID SARS-CoV-2 Device ID: 2108 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Alfa Scientific Designs Inc. Commercial: Instant-view® PLUS COVID-19 Antigen Test Device ID: 1678 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMEDA Labordiagnostik GmbH Commercial: Rapid Test SARS-CoV-2 Ag Device ID: 1602 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva Device ID: 2604 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold) Device ID: 1822 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. Commercial: COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold) - (Nasal swab/saliva) Device ID: 1589 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AnTaimmu BioMed Commercial: COVID-19 Antigen Rapid Test (Vstrip) Device ID: 1451 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Apollo Biomedical LLC Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) Device ID: 1289 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ArcDia International Ltd. Commercial: mariPOC Quick Flu+ Device ID: 2079 Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ArcDia International Ltd. Commercial: mariPOC Respi+ Device ID: 2078 Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ArcDia International Ltd. Commercial: mariPOC SARS-CoV-2 Device ID: 768 Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ARISTA Biotech Pte. Ltd. Commercial: ARISTA™ COVID-19 Antigen Rapid Test Device ID: 1926 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 & Influenza A/B Antigen Combo Test Device Device ID: 1371 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit Device ID: 3106 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 & M. pneumoniae Antigen Combo Test Device Device ID: 1372 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Device Device ID: 24760 Method: Immunoassay Target: Antigen Format: 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: COVID-19 Antigen Saliva Test Kit Device ID: 1579 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 Antigen Saliva Test Kit Device ID: 2037 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19& Influenza A/B& RSV Antigen Combo Rapid Test Device ID: 5824 Method: Immunoassay 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 (Nasal swab, Nasopharyngeal swab, Oropharyngeal swab) Device ID: 770 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 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: ECOTEST COVID-19 Antigen Rapid Test Device Device ID: 4075 Method: Immunoassay 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: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device Device ID: 1370 Method: Immunoassay Target: Antigen Format: Near POC / POC 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: 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: 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: 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: 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: Beijing Applied Biological Technologies Co. Ltd. Commercial: 2019-nCoV Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab Device ID: 3062 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Device ID: 2839 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab Device ID: 3063 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) Device ID: 1283 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Device ID: 3622 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva Device ID: 1798 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test Device ID: 1725 Method: Immunoassay Target: Antigen Format: Near POC / POC 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