| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Bioneovan Co. Ltd. | Commercial: Bioneovan COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 2077 | Method: Immunochromatography | Target: Antigen | 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: Bionote Inc. | Commercial: NowCheck COVID-19 Ag Test | Device ID: 1242 | Method: Immunoassay | Target: Antigen | Format: 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: Biopanda Reagents | Commercial: COVID-19 Rapid Antigen Test | Device ID: 2034 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioscience(Tianjin) Diagnostic Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Rapid Test | Device ID: 2623 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: BioSpeedia COVID19 Nasal Antigen Test BSD_506 | Device ID: 2381 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: BioSpeedia COVID19 Non-Invasive Antigen Test BSD_504 | Device ID: 2379 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: COVID19Speed-Antigen Test BSD_0503 | Device ID: 2380 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX AMPLIQUICK Respiratory Triplex | Device ID: 1352 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 Ag BSS | Device ID: 1223 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 Ag+ BSS | Device ID: 1494 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: BIOSYNEX S.A. | Commercial: BIOSYNEX COVITOP | Device ID: 2947 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) | Device ID: 5827 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) | Device ID: 25541 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) | Device ID: 25545 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 3487 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 5853 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (anterior nasal swab) | Device ID: 5852 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) | Device ID: 2067 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) nasal swab | Device ID: 2068 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioteke Taizhou Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) | Device ID: 1487 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biotical Health S.L.U. | Commercial: biotical SARS-CoV-2 Ag Card | Device ID: 2013 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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: Biozek Medical | Commercial: Covid-19 IgG/IgM Rapid Test | Device ID: 1012 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Birmingham Biotech Ltd. | Commercial: BHM COVID-19 Antigen Rapid Test | Device ID: 3008 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Birmingham Biotech Ltd. | Commercial: BHM COVID-19 Antigen Sealing Tube Test Strip | Device ID: 3007 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Blue Cross Bio-Medical（Beijing） Co. Ltd. | Commercial: COVID-19 Antigen Test | Device ID: 2627 | Method: Immunoassay | Target: Antigen | Format: Manual | 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, IgA, IgG, IgM | Format: Automated, Near POC / POC | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) | Device ID: 1605 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1828 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: SARS-CoV-2 Antigen Rapid test | Device ID: 1964 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 Ag | Device ID: 1989 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 SP/NP IgG | Device ID: 2783 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19/Flu Ag Combo | Device ID: 1449 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Ichroma COVID-19 Ab, IgM/IgG | Device ID: 837 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 Ag | Device ID: 1990 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test | Device ID: 1236 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid) | Device ID: 1684 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag Nasal | Device ID: 2691 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CAMP MEDICA DISTRIBUTION | Commercial: See Now Coronavirus nCoV antigen test | Device ID: 1999 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | 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 |
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