| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1155 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1186 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eco Diagnostica Ltd.a | Commercial: COVID-19 IgG/IgM ECO Teste | Device ID: 672 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Advagen Biotech Ltd. | Commercial: COVID-19 IgG/IgM LF | Device ID: 818 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | 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: Zenum Technologies | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1031 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Assut Europe | Commercial: Covid-19 IgG/IgM RAPID TEST | Device ID: 1036 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1321 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1381 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 646 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (cassette) | Device ID: 1389 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: AIVD Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 18 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPRING HEALTHCARE SERVICES SP Z O O | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 618 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) | Device ID: 1479 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (Strip) | Device ID: 1394 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2439 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1377 | 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: Acro Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 465 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Syrona Limited | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 619 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1970 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai International Holding Corp. GmbH(Europe) (DE) | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 987 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 212 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genitech NSAN Pharmaceutical Pvt. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 563 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 677 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 664 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shenzhen Landwind Medical | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 691 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 1912 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual, 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Dipstick | Device ID: 1382 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Kit | Device ID: 651 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Test Cassette | Device ID: 1475 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 IgG/IgM Test Cassette (for Analyzer) | Device ID: 1676 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2393 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2416 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 857 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: Covid-19 IgG/IgM test kit (Colloidal Gold Method) | Device ID: 1001 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hecin Scientific Inc. | Commercial: COVID-19 IgM Antibody Rapid Test Kit | Device ID: 478 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Ab Test | Device ID: 132 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Antibody Rapid Detection Kit(colloidal gold method) | Device ID: 2823 | Method: Immunoassay | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin Era Biology Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Lateral Flow Assay | Device ID: 624 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WHPM | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 1630 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Well Biotech | Commercial: COVID-19 IgM/IgG Rapid Test (Colloidal Gold) | Device ID: 1027 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: COVID-19 IgM/IgG Rapid Test Cassette | Device ID: 276 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ring Biotechnology Co. Ltd. | Commercial: COVID-19 IgM/IgG Rapid Test Kit | Device ID: 603 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Abbott | Commercial: COVID-19 LAB TEST TO DETECT ANTIBODIES | Device ID: 754 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Detection Kit | Device ID: 2305 | Method: Immunoassay | Target: Antibody | Format: Manual, 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