| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: /COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal - self testing device | Device ID: 2875 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shandong ThinkLab Biotechnology Co. Ltd. | Commercial: 09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) | Device ID: 945 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Biomeme | Commercial: 10 Minutes COVID-19 IgG/IgM Rapid Test | Device ID: 92 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: 2019 nCOV IgG/IgM Rapid Test | Device ID: 152 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Microtrace Diagnostici SRL | Commercial: 2019 NCOV IGG/IGM TEST | Device ID: 1020 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Device ID: 156 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019- nCoV Antigen Rapid Test | Device ID: 1873 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: 2019-nCoV Ab Test (Colloidal Gold) | Device ID: 1000 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Device ID: 227 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Nasopharyngeal Swab) | Device ID: 2504 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Oropharyngeal swab) | Device ID: 2509 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) | Device ID: 1994 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) (Anterior Nasal Swab) | Device ID: 2910 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV Antigen Control (CLIA) | Device ID: 1703 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV Antigen Control (IFA) | Device ID: 1704 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Antigen Device | Device ID: 1202 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Colloidal Gold) | Device ID: 1273 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette | Device ID: 3068 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette Anterior Nasal Swab | Device ID: 3058 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab | Device ID: 3062 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette Saliva | Device ID: 3060 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) | Device ID: 1283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen AmonMed Biotechnology Co. Ltd. | Commercial: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | Device ID: 959 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgG Antibody Determination Kit | Device ID: 63 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV IgG Control | Device ID: 1084 | Method: Immunoassay | Target: Antibody, IgG | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Intermedical SRL | Commercial: 2019-NCOV IGG/IGM | Device ID: 1011 | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgG/IgM Antibody Rapid Test Kit | Device ID: 960 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV IgG/IgM Device | Device ID: 1048 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: TD diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1628 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 568 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 88 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 208 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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, IgG, IgM | Format: Near POC / POC | 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: CITEST DIAGNOSTICS Inc. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2438 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: 2019-nCoV IgG/IgM Rapid Test Dipstick | Device ID: 674 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: 2019-nCoV IgG/IgM Rapid Testing Kit | Device ID: 766 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: U2USystems (India) Pvt. Ltd. | Commercial: 2019-ncoV IgG/IgM Test | Device ID: 489 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prometheus Bio Inc. | Commercial: 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) | Device ID: 868 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: 2019-nCOV IgG/LgM Rapid Test Device | Device ID: 570 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgM Antibody Determination Kit | Device ID: 62 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV IgM Control | Device ID: 1085 | Method: Immunoassay | Target: Antibody, IgM | Format: Other | 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: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 1807 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method) | Device ID: 3048 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) | Device ID: 1879 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (colloidal gold method) | Device ID: 1811 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Matridx Biotechnology Co. Ltd. | Commercial: 2019-nCov Rapid Test Kit | Device ID: 214 | Method: Immunoassay | Target: Antibody | Format: Manual | 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