| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 2704 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Bioworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 3088 | Method: Chromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: JINAN BABIO BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) | Device ID: 2151 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JINAN BABIO BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) | Device ID: 4046 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen CAS-Envision Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit | Device ID: 2152 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit | Device ID: 3079 | 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 Test (Fluorescence Immunochromatography)-Blood | Device ID: 2693 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab | Device ID: 2692 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | 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: ELISA | 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: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit SWAB | Device ID: 2026 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit SALIVA | Device ID: 2295 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit NASAL | Device ID: 3029 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dianext | Commercial: SARS-CoV-2 antigen Immunofluorescence assay | Device ID: 2568 | Method: Immunochromatography | Target: Antigen | Format: Semi-automated | 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: Getein Biotech Inc. | Commercial: SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay) | Device ID: 2591 | Method: Immunoassay | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 Antigen ELISA | Device ID: 2289 | Method: ELISA | Target: Antigen | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method) | Device ID: 3018 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Sampling by gargle or oropharyngeal wash) | Device ID: 2121 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Biocup Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay) | Device ID: 1950 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Aivd Biotechnology Co.LTD. | Commercial: SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay) | Device ID: 2834 | Method: Other | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NINGBO LVTANG BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Device ID: 4049 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) | Device ID: 2116 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biosino Bio-Technology and Science Inc. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) | Device ID: 2856 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, 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: 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: Yixin Bio-Tech (Guangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Assay Kit (Immunochromatography Method) | Device ID: 3020 | 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) (self-test) | Device ID: 2987 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: 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: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen (GICA) | Device ID: 1711 | Method: Immunochromatography | Target: Antigen | 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: Labnovation Technologies, Inc. | Commercial: SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit(Immunochromatography) | Device ID: 3928 | Method: | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: SARS-CoV-2 Antigen Influenza A B Rapid Test Kit(Immunochromatography) | Device ID: 3936 | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: SARS-CoV-2 Antigen | Device ID: 2061 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: SARS-CoV-2 Antigen | Device ID: 2457 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: 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: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) | Device ID: 523 | Method: Immunochromatography | Target: Antibody | 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 UK Ltd. | 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: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) | Device ID: 310 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antibody Assay (CLIA) | Device ID: 2213 | Method: CLIA | Target: Antibody | Format: Automated | 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: 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: 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: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette For self-testing use only | Device ID: 3167 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 and Influenza A+B Antigen Combo Test Kit (Colloidal Gold) | Device ID: 3986 | Method: Immunochromatography | 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