CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag Nasal | Device ID: 2691 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST | Device ID: 2696 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASOPHARYNGEAL ANTIGEN TEST | Device ID: 2746 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co.,Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Device ID: 2588 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | Commercial: CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette) | Device ID: 1691 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing M&D Biotechnology Co. Ltd | Commercial: 2019-nCoV Antigen Test Kit | Device ID: 2150 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 Antigen Rapid Test (Nasal Swab) | Device ID: 2449 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech, Inc | Commercial: OnSite COVID-19 Ag Rapid Test | Device ID: 1581 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC | Commercial: Test Rapid Covid-19 Antigen (tampon nazofaringian) | Device ID: 1225 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 Ag Cassette | Device ID: 1375 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON® SARS-CoV-2 Ag | Device ID: 1960 | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | Go to details |
CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: COVID-19 Antigen Detection Kit | Device ID: 2242 | 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: Dräger Safety AG & Co. KGaA | Commercial: Dräger Antigen Test SARS-CoV-2 | Device ID: 2273 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology(Tianjin) Co., Ltd. | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Device ID: 2533 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: ActivXpress+ COVID-19 Antigen Complete Testing Kit | Device ID: 1243 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EBS SARS-CoV-2 Ag Rapid Test | Device ID: 1739 | Method: Immunoassay | 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: Immunoassay | Target: Antigen | Format: 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 Test | Device ID: 1855 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: 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: GenSure Biotech Inc | Commercial: GenSure COVID-19 Antigen Rapid Kit | Device ID: 1253 | Method: Immunoassay | 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: 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: 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: 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: 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 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 |
CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: COVID-19 Ag Test Kit | Device ID: 1360 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography) | Device ID: 1324 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: CVAG4080A – GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP Swab) | Device ID: 2319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) | Device ID: 2325 | 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 (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: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) | Device ID: 2302 | 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: Hangzhou Biotest Biotech Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Cassette(Nasal Swab) | Device ID: 1876 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: COVID-19 Antigen Rapid Test | Device ID: 1363 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Cassette (Nasal Swab) | Device ID: 1610 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test | Device ID: 1365 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd. | Commercial: COVID-19 Antigen Test Cassette | Device ID: 2629 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: Hangzhou GENESIS Biodetection and Biocontrol CO.,LTD | Commercial: KaiBiLi COVID-19 Antigen Pro | Device ID: 2885 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Jucheng Medical Products Co., Ltd | Commercial: SARS-CoV-2 Ag Rapid Test Kit | Device ID: 2979 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co., Ltd | Commercial: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Device ID: 1215 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD. | Commercial: COVID-19 Antigen Rapid Test Device(Colloidal Gold) | Device ID: 2139 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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 |
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