| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunoassay | Target: Antigen | 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, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Alphadia | Commercial: Alphadia | Device ID: 1803 | Method: Immunoassay | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela Covid-19 Antigen test | Device ID: 829 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | 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, IgG, IgM | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: AndLucky COVID-19 Antigen Rapid Test | Device ID: 1296 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin MNCHIP Technologies Co., Ltd | Commercial: Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) | Device ID: 404 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: H&Z Life Science Co. Ltd | Commercial: Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay) | Device ID: 1172 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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, IgG | 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: Silversite diagnostics.corp | Commercial: Antibody kit igg igm testing | Device ID: 1731 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lifotronic Technology Co, Ltd | Commercial: Antigen Rapid Test Ag SARS-CoV-2 | Device ID: 1592 | 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: Core Technology Co., Ltd | Commercial: Antigen Rapid Test COVID-19 Coretests | Device ID: 1594 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc | Commercial: Artron COVID-19 IgM/IgG Antibody Test | Device ID: 1729 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 Ag | Device ID: 1654 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 IgG/IgM | Device ID: 1760 | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: ASSURE SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 937 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Atellica IM SARS-CoV-2 Antigen (CoV2Ag) | Device ID: 2015 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Atellica IM SARS-CoV-2 IgG (sCOVG) | Device ID: 2023 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | 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: 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: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 Ag RAPID | Device ID: 2125 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 IgM/IgG RAPID | Device ID: 2126 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BBB Inc. | Commercial: BBB Inc. | Device ID: 2315 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Kit For Rapid Detection of SARS-CoV-2 | Device ID: 2282 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCoV IgG | Device ID: 1499 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov IgM | Device ID: 1500 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov Total Ig | Device ID: 1498 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: Biocard Covid-19 Rapid Test | Device ID: 1116 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioVendor | Commercial: BIOCREDIT COVID-19 Ag | Device ID: 335 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc | Commercial: BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test | Device ID: 1606 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc | Commercial: BIOCREDIT COVID-19 IgG+IgM Duo | Device ID: 336 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc | Commercial: BIOCREDIT COVID-19 IgG/IgM Combo | Device ID: 1716 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd | Commercial: Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) | Device ID: 365 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd | Commercial: Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test | Device ID: 689 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica, Inc. | Commercial: Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) | Device ID: 1599 | Method: Immunoassay | Target: Antigen | 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, IgG, IgM | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 Ag+ BSS | Device ID: 1494 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: 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: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CAT | Device ID: 1199 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: CerTest SARS-CoV-2 Card test | Device ID: 1173 | Method: Immunoassay | 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: Shanghai Chemtron Biotech Co., Ltd. | Commercial: Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) | Device ID: 2312 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co., Ltd. | Commercial: Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold) | Device ID: 2313 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co., Ltd. | Commercial: Chemtrue® COVID-19 （SARs-Cov-2）Antigen Rapid Test Kit (Nasal Swab) | Device ID: 2512 | 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