CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
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: 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: 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: 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: 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 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: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1341 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: Immunochromatography | Target: Antigen | Format: Manual, 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: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2756 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Rapid Labs Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 5812 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2230 | Method: Immunochromatography | 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 (Colloidal Gold) | Device ID: 1884 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: 1257 | 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: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 3093 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Rapid Labs Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal Swab) | Device ID: 3096 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 1945 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2029 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2671 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva) | Device ID: 1952 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SPRING HEALTHCARE SERVICES SP Z O O | 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: Hangzhou Funworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Device | Device ID: 2862 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) 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: 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, Other | Go to details |
CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2090 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: Wuhan Uni-science Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 4111 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1764 | 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 Rapid Test Kit (Fluorescence Immunochromatography) | Device ID: 1286 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | Device ID: 1266 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Huaree Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | Device ID: 2812 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Cassette | Device ID: 2586 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hubei Jinjian Biology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 1759 | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Ultra-Diagnostics Biotec. Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 2017 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 5853 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1967 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) | Device ID: 2067 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2012 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2414 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Sars-CoV-2 antigen test kit (colloidal gold) | Device ID: 2415 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2742 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay) | Device ID: 1968 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA) | Device ID: 1813 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Medomics medical technology Co. Ltd. | Commercial: SARS-CoV-2 antigen Test Kit (LFIA) | Device ID: 2006 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Cofoe Medical Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method) | Device ID: 3937 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Wuxi Biohermes Bio & Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit(Lateral Flow Assay) | Device ID: 2143 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Tongzhou Biotechnology Co Ltd | Commercial: SARS-CoV-2 Antigen Test(nasopharyngeal swab) | Device ID: 24766 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | Device ID: 2164 | Method: Immunoassay | Target: Antigen | Format: Manual, 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