| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Platelia SARS-CoV-2 Total Ab Assay | Device ID: 756 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit | Device ID: 2703 | Method: Chromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold） | Device ID: 2895 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biocan Diagnostics Inc. | Commercial: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test | Device ID: 524 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocheck GmbH | Commercial: Anti-SARS-CoV-2 IgG | Device ID: 1099 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1686 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: BOH-180 Fluorescent Immunoassay Analyzer | Device ID: 2694 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) | Device ID: 87 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH S.L. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1829 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | Device ID: 497 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMARIC | Commercial: SARS-CoV-2 Total Ab ELISA | Device ID: 2639 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 88 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgG | Device ID: 881 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgM | Device ID: 957 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 90 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 IgG/IgM Rapid Strip Test (1507B) | Device ID: 1603 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 IgG/IgM Rapid Test (1507A) | Device ID: 1601 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold) | Device ID: 2205 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biopanda Reagents | Commercial: COVID-19 Rapid Antibody Test | Device ID: 1016 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biosino Bio-Technology and Science Inc. | Commercial: SARS-COV-2 Antibody Test | Device ID: 778 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Biosino Bio-Technology and Science Inc. | Commercial: SARS-CoV-2 Neutralizing antibody Test KIT (Colloidal gold) | Device ID: 2865 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biosino Bio-Technology and Science Inc. | Commercial: SARS-CoV-2 Neutralizing antibody Test Kit (ELISA) | Device ID: 2857 | Method: ELISA | Target: Antibody | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 BSS | Device ID: 779 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Bioteke Taizhou Biotechnology Co. Ltd. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 1488 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biozek Medical | Commercial: Covid-19 IgG/IgM Rapid Test | Device ID: 1012 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biozek Medical | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 464 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BluSense Diagnostics ApS | Commercial: ViroTrack Sero COVID-19 IgA+IgM/IgG Ab | Device ID: 103 | Method: Immunoassay | Target: Antibody | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BluSense Diagnostics ApS | Commercial: ViroTrack Sero COVID-19 Total Ab | Device ID: 2906 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time 2019-nCoV IgG/IgM Rapid Test | Device ID: 1168 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 2194 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 Ab, IgM/IgG | Device ID: 836 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 nAb | Device ID: 2399 | Method: Immunoassay | Target: Antibody | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 SP/NP IgG | Device ID: 2783 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Boditech Quick™ COVID-19 Neutralizing Ab | Device ID: 2785 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Ichroma COVID-19 Ab, IgM/IgG | Device ID: 837 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 nAb | Device ID: 2398 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 SP/NP IgG | Device ID: 2784 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Rapid Test Device | Device ID: 2033 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: Camtech COVID-19 Rapid Test Kit | Device ID: 111 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CAS-Envision | Commercial: SARS-CoV-2 Neutralizing Antibodies Test Kit | Device ID: 2788 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cell ID Pte Ltd. | Commercial: Smart COVID-19 IgM/IgG RDT | Device ID: 838 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cellex Inc. | Commercial: Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test | Device ID: 116 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changsha Sinocare Inc. | Commercial: SARS-CoV-2 Antibody Test Strip | Device ID: 460 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CHIL Medical Supplies Ltd. | Commercial: CHiL COVID-19 IgG/IgM Rapid Test cassette | Device ID: 1098 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit | Device ID: 1939 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (QDs) | Device ID: 1940 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing Novegent Biotech Company Limited | Commercial: Novegent COVID-19 Antibodies Rapid Test Kit | Device ID: 1185 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 1390 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2438 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2435 | Method: Immunoassay | Target: Antibody | 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