| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd. | Commercial: SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2233 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2231 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: 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: 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: 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: 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: Shenzhen Kisshealth Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay) | Device ID: 1817 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: SARS-CoV-2 Antibody | Device ID: 1018 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: SARS-CoV-2 Antibody (IgM/IgG) | Device ID: 1017 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: INNOVITA (Tangshan) Biological Technology Co., Ltd. | Commercial: SARS-CoV-2 antibody assay | Device ID: 641 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kurabo Industries Ltd | Commercial: SARS-CoV-2 Antibody IgM/IgG Testing Kit | Device ID: 254 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biosino Bio-Technology and Science Inc | Commercial: SARS-COV-2 Antibody Test | Device ID: 778 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDX | Commercial: SARS-CoV-2 Antibody Test | Device ID: 1147 | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changsha Sinocare, Inc | Commercial: SARS-CoV-2 Antibody Test Strip | Device ID: 460 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sinocare | Commercial: SARS-CoV-2 Antibody Test strip (colloidal Gold Method) | Device ID: 990 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: SARS-CoV-2 Antigen (Colloidal Gold) | Device ID: 1820 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen (GICA) | Device ID: 2148 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) | Device ID: 2201 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography method | Device ID: 1659 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method | Device ID: 1660 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wenzhou OJA Biotechnology Co., LTD. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Device ID: 1575 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Jiqing Biomedical Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Device ID: 1588 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Savant Biotechnology Co., Ltd | Commercial: SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit | Device ID: 1235 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 Antigen Kit (Colloidal Gold) | Device ID: 1197 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd | Commercial: SARS-CoV-2 Antigen quantitative assay kit (Enzyme-linked immunoassay) | Device ID: 1293 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Qualitative Test | Device ID: 1685 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ASSUT EUROPE SPA | Commercial: SARS-CoV-2 Antigen Rapid Swab | Device ID: 2248 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1338 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1456 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd | Commercial: SARS-COV-2 Antigen Rapid Test | Device ID: 1616 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co.,Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2317 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: POLY-DETECH RAPIDTECH | Commercial: SARS-CoV-2 antigen rapid test | Device ID: 2483 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test) (Swab) | Device ID: 2384 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Device ID: 1341 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHANDONG KANGHUA BIOTECHNOLOGY CO., LTD | Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Device ID: 1366 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 2257 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 2267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) for self testing | Device ID: 2529 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Device ID: 1865 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Device ID: 1908 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: SARS-CoV-2 Antigen Rapid Test (Swab) | Device ID: 1948 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spring Healthcare Services AG | Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (Saliva) | Device ID: 1901 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spring Healthcare Services AG | Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (swab) | Device ID: 1780 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 1266 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 1465 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Wuhan UNscience Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 1600 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) Co., LTD. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2074 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Anterior Nasal | Device ID: 1841 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay) | Device ID: 1655 | Method: Immunoassay | Target: Antigen | 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