| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SureStatus COVID-19 (SARS-CoV-2) Card Test | Device ID: 317 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SureStatus COVID-19 (SARS-CoV-2) EIA Test | Device ID: 316 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG Biotechnology Corp. | Commercial: TBG SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 1336 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Telepoint Medical Services LLC | Commercial: Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test | Device ID: 399 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocan Diagnostics Inc. | Commercial: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test | Device ID: 524 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen | Device ID: 1305 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian)) | Device ID: 1226 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Lifeassay Diagnostics Pty Ltd. | Commercial: Test-it COVID-19 IgM/IgG Lateral Flow Assay | Device ID: 259 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: TGS Velox Ag COVID-19 POCT SALIVA (25 test) | Device ID: 2274 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Absea Biotechnology Ltd. | Commercial: The non-invasive MEGA test of SARS-CoV-2 | Device ID: 9 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. | Commercial: Tigsun COVID-19 Antigen Rapid Test | Device ID: 1292 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. | Commercial: Tigsun COVID-19 Antigen Saliva Rapid Test | Device ID: 1290 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. | Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) | Device ID: 77 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA CORONADIAG Ag | Device ID: 1466 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: Toyo SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1723 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Trichomonas Vaginalis Antigen Rapid Test Cassette | Device ID: 3140 | Method: Immunoassay | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: TP Medicare GmbH | Commercial: Trueline COVID-19 Ag Rapid Test | Device ID: 1497 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Henan UDX Biotechnology Co. Ltd. | Commercial: UDXBIO | Device ID: 2946 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience Covid-19 Rapid Antigen Saliva Test | Device ID: 2522 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience® COVID-19 Ag Home Test | Device ID: 2826 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: UNICELL-2019-nCoV Ag | Device ID: 1170 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: UNICELL-2019-nCoV NAb | Device ID: 1478 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | 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 Speichel Schnelltestkarte HGH | Device ID: 2244 | Method: Immunoassay | 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: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) | Device ID: 1319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) | Device ID: 1357 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (IFA) | Device ID: 1317 | 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: Michael Bubolz GmbH | Commercial: Vibamat | Device ID: 4148 | Method: Immunoassay | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgG | Device ID: 881 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgM | Device ID: 957 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Fjord Diagnostics SDN | Commercial: Viral Transport Medium | Device ID: 551 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Naturitious LLC | Commercial: Viralert COVID-19 IgG/IgM Antibody Rapid Test Kit | Device ID: 484 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: VIROTECH SARS-CoV-2 IgG | Device ID: 880 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BluSense Diagnostics ApS | Commercial: ViroTrack Sero COVID-19 IgA+IgM/IgG Ab | Device ID: 103 | Method: Immunoassay | Target: Antibody, IgA, IgG, IgM | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BluSense Diagnostics ApS | Commercial: ViroTrack Sero COVID-19 Total Ab | Device ID: 2906 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal ( SGA Muhendislik Dans Egt Ic ve Dis Tic A.S.) | Commercial: ViruScan SARS-CoV-2 Rapid Antigen Test | Device ID: 5732 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co. Ltd. | Commercial: Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 2642 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Åžirketi | Commercial: VISION® COVID-19 AG RAPID TEST | Device ID: 2070 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag COVID-19 IgM/IgG Rapid Test | Device ID: 428 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Ag Saliva Rapid Test | Device ID: 1980 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Panion & BF Biotech Inc. | Commercial: Vstrip Covid-19 Antigen Rapid Test | Device ID: 1379 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: VTRUST COVID-19 Antigen Rapid Test TD-4531 | Device ID: 1096 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: Wantai SARS-CoV-2 Ab Rapid Test | Device ID: 82 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: Willi Fox COVID-19 Antigen rapid Test | Device ID: 1276 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: Willi Fox Covid-19 IgM/ IgG rapid test | Device ID: 633 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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 |
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