CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: COVID-19 Ag Test Kit | Device ID: 1360 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Test Kit | Device ID: 1668 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: Flu+COVID-19 Ag Test Kit | Device ID: 1470 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-CHEK 2019-nCoV Ag & FLU A/B Combo Rapid Test | Device ID: 1318 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-CHEK 2019-nCoV Ag Rapid Test Kit | Device ID: 1316 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-Chek 2019-nCoV Ag Rapid Test Kit (Immunochromatography) | Device ID: 5762 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-Chek 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography) | Device ID: 5763 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-CHEK SARS-CoV-2 Ag Rapid Test Kit | Device ID: 1314 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-CHEK, 2019-nCoV Ag & FLU A/B Combo Rapid | Device ID: 1325 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography) | Device ID: 1883 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay) | Device ID: 1326 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography) | Device ID: 1324 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Dongsheng Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test (Lateral Flow Method) | Device ID: 3094 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Pluslife Biotech Co. Ltd. | Commercial: Pluslife SARS-CoV-2 Card | Device ID: 2958 | Method: Other | Target: Nucleic acid | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Weimi Bio-Tech Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 3459 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: 2019-nCoV Antigen Test (Lateral Flow Method) | Device ID: 3991 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: 2019-nCoV Antigen Test (Lateral Flow Method) - Nasal and Saliva | Device ID: 3992 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Finecare SARS-CoV-2 Antibody Test | Device ID: 206 | 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 IgG Test | Device ID: 1191 | Method: Immunoassay | Target: Antibody, IgG | 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, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Nasal swab | Device ID: 1312 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Nasopharyngeal/Oropharyngeal/Nasal swab | Device ID: 3589 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Self-test | Device ID: 2908 | Method: Immunochromatography | Target: Antigen | 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 Antigen Test (Lateral Flow Method) | Device ID: 1214 | Method: Immunoassay | Target: Antigen | 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, IgG | 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, IgM | 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, IgM | 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, 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: 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: 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: Hangzhou Aichek Medical Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 3005 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co Ltd | Commercial: SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) for self testing | Device ID: 4107 | Method: Immunoassay | Target: Antigen | 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: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test | Device ID: 1256 | Method: Immunoassay | Target: Antigen | 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, IgG | 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, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test (Oral Fluid) | Device ID: 1947 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test (Oral Fluid) SELFTESTING | Device ID: 2159 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Test cassette (FIA) | Device ID: 1254 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) | Device ID: 2302 | Method: Immunoassay | Target: Antigen | 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, IgG | 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, IgG | 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, 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: 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: Hangzhou AllTest Biotech Co. Ltd. | Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) | Device ID: 2325 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) for self testing | Device ID: 2690 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 1258 | Method: Immunochromatography | 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