CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) | Device ID: 1599 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Bionote Inc. | Commercial: NowCheck COVID-19 Ag Test | Device ID: 1242 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Bioscience(Tianjin) Diagnostic Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Rapid Detection kit | Device ID: 2858 | Method: RT-PCR | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: COVID19Speed-Antigen Test BSD_0503 | Device ID: 2380 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 Ag BSS | Device ID: 1223 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 Ag+ BSS | Device ID: 1494 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) | Device ID: 5827 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: 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: Biotical Health S.L.U. | Commercial: biotical SARS-CoV-2 Ag Card | Device ID: 2013 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 Ag | Device ID: 1989 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test | Device ID: 1236 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
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: CerTest Biotec | Commercial: CerTest SARS-CoV-2 | Device ID: 1173 | Method: | Target: Antigen | Format: Manual, 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: Chastru Biotech Limited | Commercial: COVID-19 Antigen Test Cassette | Device ID: 3966 | Method: Immunochromatography | Target: Antigen | Format: 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 (Nasal / Nasopharyngeal / Oropharyngeal Swab-Casette) | Device ID: 1691 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 2031 | 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 (Swab) | Device ID: 2449 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)(FIA) | Device ID: 2388 | Method: Immunoassay | 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: 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 SRL | 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: Immunochromatography | 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: 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: 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: 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: 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: 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) | 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: 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 |
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