| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Finecare™ 2019-nCoV Antigen Test | Device ID: 2929 | Method: Immunoassay | Target: Antigen | 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: SARS-CoV-2 Real-Time RT-PCR Assay | Device ID: 1131 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Device ID: 1437 | 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)-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: No | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo SARS-CoV-2 Nucleic Acid Detection Kit | Device ID: 205 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Guangzhou Yunrui Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Testing kit(Colloidal Gold) | Device ID: 2904 | Method: ELISA | Target: Antigen | Format: Manual | 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: GVS S.p.A. | Commercial: Flame CoViD -19 VARIANTS qPCR Master Kit – CE-IVD | Device ID: 2445 | Method: RT-PCR | Target: | Format: Fully automated (robot), Lab-based, Manual, Semi-automated | 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: No | Manufacturer: H-Guard | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Device ID: 1636 | 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: 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: HA TECH PTY Ltd. | Commercial: SARS-CoV-2 RT-PCR Multiplex Diagnostic Kit (NAT-01) | Device ID: 2698 | Method: RT-PCR | Target: | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hackensack Meridian Health CDI | Commercial: SARS-COV-2 test | Device ID: 207 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | Commercial: CDI Enhanced COVID-19 Test | Device ID: 726 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hain Lifescience a Bruker company | Commercial: FluoroType® SARS-CoV-2 evo | Device ID: 2972 | Method: RT-PCR | Target: | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Hain Lifescience a Bruker company | Commercial: FluoroType® SARS-CoV-2 plus | Device ID: 2880 | Method: RT-PCR | Target: Nucleic acid | Format: Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Hain Lifescience a Bruker company | Commercial: FluoroType® SARS-CoV-2 varID Q | Device ID: 2970 | Method: RT-PCR | Target: | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Hain Lifescience a Bruker company | Commercial: FluoroType® SARS-CoV-2/Flu/RSV | Device ID: 2971 | Method: RT-PCR | Target: | Format: Semi-automated | 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: 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: 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 (Nasopharyngeal Swab) | Device ID: 2389 | Method: Immunoassay | 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) | 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 Rapid Test (Swab)(NP) | Device ID: 2402 | 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: 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 AllTest Biotech Co. Ltd. | Commercial: COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2327 | Method: Immunoassay | Target: Antibody, IgG | 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