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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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1828 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: ACON Laboratories, Inc Commercial: Flowflex SARS-CoV-2 Antigen rapid test Device ID: 1468 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ACON Laboratories, Inc Commercial: Foresight SARS-CoV-2 IgG EIA Test Kit Device ID: 1671 Method: Immunoassay Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: ACON Laboratories, Inc Commercial: Foresight SARS-CoV-2 IgM EIA Test Kit Device ID: 1672 Method: Immunoassay Target: Antibody, IgM Format: Automated, Manual 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: ACON Laboratories, Inc Commercial: SARS-CoV-2 Antigen Rapid Test Strip Device ID: 1907 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ACON Laboratories, Inc. Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) Device ID: 2452 Method: Immunochromatography Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette Device ID: 1696 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Device ID: 2434 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2391 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test Device ID: 1698 Method: Immunoassay Target: Antibody, IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) Package Insert Device ID: 2420 Method: Immunoassay Target: Antibody, IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test Device ID: 1697 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) Device ID: 2412 Method: Immunoassay Target: IgG, IgM 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 (Nasopharyngeal Swab) Device ID: 2432 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: COVID-19 IgG Rapid Test Device ID: 1695 Method: Immunoassay Target: Antibody, IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) Device ID: 2427 Method: Immunoassay Target: Antibody, IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) Device ID: 1677 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) Device ID: 2433 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 IgG/IgM Rapid Test Cassette Device ID: 465 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 IgG/IgM Rapid Test Dipstick Device ID: 1694 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: COVID-19 IgG/IgM Test Cassette (for Analyzer) Device ID: 1676 Method: Immunoassay Target: IgG, IgM 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: Acro Biotech Inc Commercial: SARS-CoV-2 Antigen Rapid Test (Swab) Device ID: 1948 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2397 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2409 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acro Biotech Inc Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2411 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ACRO BIOTECH Inc. Commercial: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) Device ID: 2417 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Actim Oy Commercial: Actim SARS-CoV-2 Device ID: 2245 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Acura Kliniken Baden-Baden GmbH Commercial: Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit Device ID: 2459 Method: Immunochromatography Target: Antibody, Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: ADALTIS srl Commercial: RAPiDgen SARS-CoV-2 Ag Test Device ID: 2896 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ADS Biotec Inc. Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) Device ID: 2448 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: No Manufacturer: ADTech Co., LTD Commercial: ADTech COVID-19 Ag RAPID KIT Device ID: 2736 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Advagen Biotech Ltd Commercial: COVID-19 IgG/IgM LF Device ID: 818 Method: Immunoassay Target: Antibody, IgG, IgM Format: Lab-based Go to details
CE Marking: Yes Manufacturer: AEHEALTH LIMITED Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 2676 Method: Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Aesku.Diagnostics Commercial: AESKULISA SARS-CoV-2 NP IgA Device ID: 1091 Method: Immunoassay Target: Antibody, IgA Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Aesku.Diagnostics Commercial: AESKULISA SARS-CoV-2 NP IgG Device ID: 1092 Method: Immunoassay Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Aesku.Diagnostics Commercial: AESKULISA SARS-CoV-2 NP IgM Device ID: 1093 Method: Immunoassay Target: Antibody, IgM Format: Automated, Manual 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: Affimedix, Inc. Commercial: InfectCheck® - COVID-19 IgG/IgM Test Device ID: 2136 Method: Immunochromatography Target: IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Affimedix, Inc. Commercial: InfectCheck® COVID-19 NAb Test Device ID: 2137 Method: Immunochromatography Target: IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Affimedix, Inc. Commercial: TestNOW® - COVID-19 Antigen Test Device ID: 2130 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Affimedix, Inc. Commercial: TestNOW® - COVID-19 IgG/IgM Test Device ID: 2132 Method: Immunochromatography Target: IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Affimedix, Inc. Commercial: TestNOW® - COVID-19 NAb Quantitative Test Device ID: 2134 Method: Immunochromatography Target: IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AIDIAN Commercial: Acro 2019-nCoV IgG/IgM pikatesti Device ID: 994 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: No Manufacturer: AIVD Biotech Inc Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) Device ID: 18 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Akralab Commercial: 2019nCoV IgG/IgM Rapid test Device Device ID: 1002 Method: Immunoassay Target: Antibody, IgG, IgM 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