| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Finecare SARS-CoV-2 IgG Test | Device ID: 1191 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Finecare SARS-CoV-2 IgM/IgG Test | Device ID: 1211 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Finecare™ 2019-nCoV RBD Antibody Test | Device ID: 2925 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo SARS-CoV-2 Antibody Test (lateral flow method) | Device ID: 461 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondof SARS-CoV-2 IgG Antibody Test (Lateral Flow Method) | Device ID: 1212 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondof SARS-CoV-2 IgM Antibody Test | Device ID: 1306 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondof SARS-CoV-2 IgM Antibody Test (Lateral Flow Method) | Device ID: 1213 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guanxhow Fenghua Bioengineering Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | Device ID: 673 | Method: Immunoassay | Target: Antibody | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HA TECH PTY Ltd. | Commercial: SARS-CoV-2 Rapid Antigen Test Kit (RAT-01) | Device ID: 4160 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HA TECH PTY Ltd. | Commercial: SARS-CoV-2 Rapid Antigen Test Kit (RAT-01) | Device ID: 4158 | Method: Immunochromatography | Target: Antibody | Format: Manual, 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test | Device ID: 1386 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo | Device ID: 1385 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG Rapid Test (cassette) | Device ID: 1383 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG Rapid Test (strip) | Device ID: 1384 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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 | 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 | 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 | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2327 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2403 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2404 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Bioer Technology Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 2059 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Protective Antibodies) | Device ID: 4123 | Method: Immunochromatography | Target: Antibody | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 1921 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Combo) | Device ID: 4114 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) | Device ID: 1922 | Method: Immunoassay | Target: Antibody | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: Clungene COVID-19 IgM/IgG Rapid Test Cassette | Device ID: 675 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Device ID: 477 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Test Device（Colloidal Gold） | Device ID: 2142 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum) | Device ID: 2141 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: 2019-nCoV-IgG Assay Reagent Kit (CMIA) | Device ID: 1793 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Assay Reagent Kit | Device ID: 1802 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel coronavirus neutralizing antibody Rapid Test Device | Device ID: 1896 | Method: Immunoassay | Target: Antibody | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette | Device ID: 2062 | Method: Immunoassay | Target: Antibody | 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: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: Covid-19 IgG/IgM test kit (Colloidal Gold Method) | Device ID: 1001 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: COVID-19 IgG/IgM Antibody Test(Colloidal Gold) | Device ID: 1632 | Method: Immunoassay | Target: Antibody | Format: Lab-based | 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 | Format: Automated, Manual | 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 | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hefei Biohit Healthcare | Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method) | Device ID: 1637 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co. Ltd. | Commercial: Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold) | Device ID: 1930 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. | Commercial: COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold) | Device ID: 2527 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test | Device ID: 5719 | Method: Immunochromatography | 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