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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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275 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
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: 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: 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: 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
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

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