CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Formosa Biomedical Technology Corp. | Commercial: Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit | Device ID: 1208 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Covid-19 Antigen CARD Kit | Device ID: 4055 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ag CARD | Device ID: 2724 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ag Test | Device ID: 2728 | Method: | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Instant COVID-19 Ag | Device ID: 2729 | Method: | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SC2 Ag Rapid | Device ID: 2723 | Method: | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: FUJIAN ERCON MEDICAL MANAGEMENT Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 3028 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: FUJIFILM Corporation | Commercial: FUJIFILM COVID-19 Ag Test | Device ID: 2428 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fujirebio | Commercial: ESPLINE SARS-CoV-2 | Device ID: 2147 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fujirebio Inc. | Commercial: Lumipulse G SARS-CoV-2 Ag | Device ID: 2124 | Method: Immunoassay | Target: Antigen | Format: Automated, Fully automated (robot), Lab-based | Go to details |
CE Marking: Yes | Manufacturer: GA Generic Assays GmbH | Commercial: GA CoV-2 Antigen Rapid | Device ID: 1580 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GA Generic Assays GmbH | Commercial: GA CoV-2 Antigen Rapid Test | Device ID: 1855 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Gaobeidian PRISES Biotechnology Co. Ltd. | Commercial: SARS-COV-2 Antigen Test | Device ID: 2781 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GC Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag | Device ID: 1144 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GC Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag (643K) | Device ID: 3190 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenaBio Diagnostics Inc. | Commercial: GenaBio SARS-CoV-2 Antigen Lateral Flow Test | Device ID: 1585 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Genalyte | Commercial: Maverick SARS-CoV-2 Multi-Antigen Serology Panel | Device ID: 721 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: GenBody Inc. | Commercial: GenBody COVID-19 Ag | Device ID: 1244 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenBody Inc. | Commercial: GenBody FIA COVID-19 Ag | Device ID: 1297 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: General Biologicals Corporation | Commercial: GB COVID-19 Ag POCT | Device ID: 4081 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Genes2me Private LTD | Commercial: RapiCov Rapid Antigen Test Kit for COVID‐19 | Device ID: 4072 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: GeneSign Biotech (Xiamen) Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Lateral Flow Assay) | Device ID: 3075 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Chlamydia Antigen Rapid Test Cassette | Device ID: 3138 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Neisseria Gonorrhoeae Antigen Rapid Test Cassette | Device ID: 3139 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1595 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: Genius Pharmaceutical AG | Commercial: GENnasal SARS-CoV-2 Antigen Rapid Test | Device ID: 3149 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Genius Pharmaceutical AG | Commercial: GENnow SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 3127 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: 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: Genrui Biotech Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (Self-Testing) | Device ID: 4159 | Method: Immunochromatography | Target: Antigen | Format: Manual, Other | Go to details |
CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: COVID-19/Flu A/B Antigen Combo Rapid Test | Device ID: 1454 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Antigen Rapid Kit | Device ID: 1253 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Antigen Rapid Test Kit | Device ID: 2853 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) | Device ID: 2590 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Device ID: 2183 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: 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: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) | Device ID: 2695 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal Gold Immunochromatography) - Nasopharyngeal | Device ID: 2800 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) - Saliva | Device ID: 2802 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCov) Antigen Test Kit (Colloidal Gold immunochromatography)- Lolly Pop | Device ID: 2777 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Test Kit (Latex Method) | Device ID: 4064 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) | Device ID: 1747 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) (for self-testing) | Device ID: 4088 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method) | Device ID: 1809 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza A/B Rapid Co-DetectionKit (Immuno-Chromatography) | Device ID: 1342 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza AB Ag RapidCo-Detection Kit (Immuno-Chromatography) | Device ID: 1323 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) | Device ID: 1216 | 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