| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Reach Diagnostic (Wuhan) Biotech Co. Ltd. | Commercial: SARS-COV-2 Ag Rapid Test | Device ID: 2954 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2538 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SARS-COV-2 Ag & Influenza Combo Rapid Test | Device ID: 1839 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: ALIMETRIX Inc. | Commercial: SARS-CoV-2 (COVID-19) serological test | Device ID: 1427 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid protein (GTX135357-pro) | Device ID: 561 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | 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: No | Manufacturer: Elabscience | Commercial: SARS-CoV-2 (2019-nCoV) IgG/IgM Lateral Flow Assay Kit (Whole Blood/ Serum/ Plasma) | Device ID: 547 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Ag Combo FIA | Device ID: 2595 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette | Device ID: 2063 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV- IgM IgG Test Kit (Colloidal Gold) | Device ID: 946 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV / SARS-CoV-2 (COVID-19) spike antibody [1A9] (GTX632604) | Device ID: 559 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Tersaco AG | Commercial: SARS CoV-2 IgG/IgM Rapid Test | Device ID: 1030 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Biogenix Inc. Pvt Ltd. | Commercial: SARS CoV-2 IgG/IgM Ab Rapid Test | Device ID: 777 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: SARA-CoV-2 Antigen Rapid Test Kit | Device ID: 1986 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2240 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2129 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1047 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Ningbo Beautiful Life Medical Biotechnology Development Co. Ltd. | Commercial: Saliva SARS-Cov-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay) | Device ID: 2250 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: S1 Covid-19 Rapid Antigen Test Kit | Device ID: 1493 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bright Line Research | Commercial: Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test | Device ID: 109 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MedMira Laboratories Inc. | Commercial: REVEALCOVID-19(TM) Total Antibody Test | Device ID: 2383 | Method: Immunoassay | Target: Antibody, IgA, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona Rapid Test | Device ID: 445 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 Antigen Rapid Test | Device ID: 448 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: reOpenTest COVID-19 Antigen Rapid Test | Device ID: 1295 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2256 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: recomWell SARS-CoV-2 IgG | Device ID: 1629 | Method: Immunoassay | Target: Antibody, IgA, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: RapiGEN Inc. | Device ID: 1832 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Weifang Kanghua Biotech | Commercial: RAPIDTECH Test Rapide Antigène SARS-CoV-2 | Device ID: 1453 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 IgG/IgM Test Kit | Device ID: 1583 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Antigen Test Kit | Device ID: 1458 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: RAPID TEST SARS-CoV-2 IgM/IgG GOLD | Device ID: 1024 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: Rapid Test SARS-CoV-2 Ag | Device ID: 1602 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Dabo Pharmaceutical Co. Ltd. | Commercial: Rapid test for IgM/IgG Antibody to SARS-CoV-2 | Device ID: 1043 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Rapid Bio LLC | Commercial: Rapid test for IgM/IgG antibodies against SARS-COV-2 | Device ID: 601 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: RAPID TEST AntigenE GCCOV-502a | Device ID: 1240 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: Rapid Test Antigen SARS- CoV-2 | Device ID: 1824 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid Test Ag 2019-nCov | Device ID: 1495 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid test 2019-nCoV Total Ig | Device ID: 1496 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd. | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 2264 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antibody Test | Device ID: 228 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antibody (IgM/IgG) | Device ID: 229 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 110 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid) | Device ID: 1684 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | Device ID: 466 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc. | Commercial: Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody) | Device ID: 1063 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold) | Device ID: 1822 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva | Device ID: 2604 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 Antigen Test | Device ID: 1735 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc. | Commercial: Rapid COVID-19 Antigen Qualitative Test Kit | Device ID: 1182 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Device ID: 297 | Method: Immunoassay | Target: Antibody | Format: Automated, 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