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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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1234 records found
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