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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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14 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test Device ID: 1725 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BiologyWorks Inc. Commercial: BiologyWorks Device ID: 2744 Method: LAMP Target: Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GeneMe Commercial: Advanced One Step FAST Covi19 KIT Two Genes Set Device ID: 177 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) Device ID: 1437 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Nasal swab Device ID: 1312 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Nasopharyngeal/Oropharyngeal/Nasal swab Device ID: 3589 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Self-test Device ID: 2908 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondfo SARS-CoV-2 Antibody Test (lateral flow method) Device ID: 461 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondof SARS-CoV-2 Antigen Test (Lateral Flow Method) Device ID: 1214 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondof SARS-CoV-2 IgG Antibody Test (Lateral Flow Method) Device ID: 1212 Method: Immunoassay Target: Antibody, IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondof SARS-CoV-2 IgM Antibody Test Device ID: 1306 Method: Immunoassay Target: Antibody, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondof SARS-CoV-2 IgM Antibody Test (Lateral Flow Method) Device ID: 1213 Method: Immunoassay Target: Antibody, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Won Medical Co. Ltd. Commercial: Wonmed Covid-19 Ag Device ID: 3038 Method: Immunochromatography Target: Antigen Format: Semi-automated Go to details
CE Marking: Yes Manufacturer: Zhejiang Quark Biotechnology Co. Ltd. Commercial: Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces) Device ID: 1322 Method: Immunoassay 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