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: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Device ID: 1004 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ | Commercial: Covid PRESTO Test rapide COVID-19 IgG/IgM | Device ID: 964 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-PRESTO | Device ID: 1835 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV- IgG/IgM | Device ID: 913 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Abbott | Commercial: SARS-CoV-2 IgG | Device ID: 701 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Abbott Ireland Diagnostics Division | Commercial: SARS-CoV-2 IgG II Quant | Device ID: 2773 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Abbott Ireland Diagnostics Division | Commercial: SARS-CoV-2 IgM | Device ID: 2774 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 IgM/IgG Combo | Device ID: 1302 | Method: Immunoassay | Target: Antibody | Format: Automated, Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Device ID: 1151 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb | Device ID: 1983 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart(TM) COVID-19 IgM/IgG | Device ID: 2573 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 IgG/IgM Cassette | Device ID: 14 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette | Device ID: 2581 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd. | Commercial: COVID-19 RAPID IgG/IgM test kit | Device ID: 762 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex Anti-SARS-CoV-2 S Antibody Rapid Test | Device ID: 2951 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Foresight SARS-CoV-2 IgG | Device ID: 1424 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Foresight SARS-CoV-2 IgM | Device ID: 1425 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD) | Device ID: 828 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 2603 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, 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 | 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 | Format: Automated, Manual | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Format: Near POC / POC | 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 | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgA | Device ID: 1091 | Method: Immunoassay | Target: Antibody | 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 | 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 | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: AIDIAN | Commercial: Acro 2019-nCoV IgG/IgM pikatesti | Device ID: 994 | Method: Immunoassay | Target: Antibody | 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 | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: DrivenFlow COVID-19 | Device ID: 21 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view PLUS COVID-19 Test | Device ID: 958 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AlphaBiolabs | Commercial: AlphaBiolabs IgM-IgG Combined Antibody Rapid Test | Device ID: 900 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 IgG/IgM | Device ID: 993 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela Covid-19 IgM IgG Combo test kit | Device ID: 830 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold) | Device ID: 2873 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV IgG/IgM Device | Device ID: 1048 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2225 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit | Device ID: 510 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Neutralizing Antibody (Double Antigen Sandwich) Test Kit (Colloidal Gold) | Device ID: 2189 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Ansh Labs | Commercial: SARS-CoV IgG ELISA | Device ID: 914 | Method: ELISA | Target: Antibody | Format: Lab-based | 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