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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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1176 records found
CE Marking Manufacturer Commercial Name Method Target Format Navigate
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co.,Ltd Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Alfa Scientific Designs, Inc. Commercial: Instant-view® PLUS COVID-19 Antigen Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Alfa Scientific Designs Inc Commercial: Instant-view PLUS COVID-19 Test Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Vitrosens Biyoteknoloji Ltd. Şti. Commercial: Instant SARS-CoV-2 Rapid Ag Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Confirm Bioscience Commercial: Instant COVID-19 “Coronavirus” Test Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: B-bio Co., Ltd. Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Eurofins_Ingenasa Commercial: INGEZIM Covid 19 DR Method: Immunoassay Target: Antibody, IgA Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Eurofins_Ingenasa Commercial: INGEZIM Covid 19 CROM Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Nantong Diagnos Biotechnology Commercial: Influenza A+B Antigen Test Kit (Colloidal Gold) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd. Commercial: Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive) Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: iFlash-SARS-CoV-2 IgM Method: Immunoassay Target: Antibody, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: iFlash-2019-nCoV NAb Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: iFlash-2019-nCoV IgA Method: Immunoassay Target: Antibody, IgA Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: iFlash-2019-nCoV Antigen Method: Immunoassay Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Innovative Diagnostics Commercial: ID Screen® SARS-CoV-2 Double Antigen Multi-species Method: Immunoassay Target: Antibody, IgA Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Innovative Diagnostics Commercial: iD Rapid® COVID-19 Antigen Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc Commercial: Ichroma COVID-19, viral Antigen Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc Commercial: Ichroma COVID-19 Ab, IgM/IgG Method: Immunoassay Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc Commercial: ichroma COVID-19/Flu Ag Combo Method: Immunoassay Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Humasis Commercial: Humasis COVID-19/Flu Ag Combo Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Humasis Commercial: Humasis COVID-19 IgG/IgM Test Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: KRISHGEN BioSystems Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Qingdao Hightop Biotech Co., Ltd Commercial: Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Philosys Co., Ltd. Commercial: Gmate® COVID-19 Ag Saliva Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Philosys Co., Ltd. Commercial: Gmate® COVID-19 Ag Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: GLINE-2019-nCoV NAb Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: GLINE-2019-nCoV IgM/IgG Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: GLINE-2019-nCoV IgA Method: Immunoassay Target: Antibody, IgA Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenSure Biotech Inc. Commercial: GenSure COVID-19 Neutralizing Antibody Test (Fluorescence) Method: Immunoassay Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: GenSure Biotech Inc Commercial: GenSure COVID-19 IgM Rapid Test (REF: P2001) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenSure Biotech Inc Commercial: GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenSure Biotech Inc Commercial: GenSure COVID-19 Antigen Rapid Kit (REF: P2004) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Applied Biological Materials Inc Commercial: GenomeCov9 IgM/IgG Rapid Test Kit Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Genelogic Research Limited Commercial: Genelogic COVID-19 IgM/IgG Antibody Test Kit Method: Immunoassay Target: Antibody, IgG, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: OSANG Healthcare Co., Ltd. Commercial: GeneFinder COVID-19 Ag Rapid Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Green Cross Medical Science Corp. Commercial: GENEDIA W ONE COVID 19 IgM&IgG Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Green Cross Medical Science Corp. Commercial: GENEDIA W COVID-19 Ag Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenBody, Inc Commercial: GenBody FIA COVID-19 Ag Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenBody, Inc Commercial: GenBody COVID-19 IgM/IgG Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenBody, Inc Commercial: Genbody COVID-19 Ag Test Method: Immunoassay 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 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 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NanoEntek Commercial: FREND COVID-19 SP Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NanoEntek Commercial: FREND COVID-19 IgG/IgM Duo Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: NanoEntek Commercial: FREND COVID-19 Ag Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Formosa Biomedical Technology Corp. Commercial: Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ACON Laboratories, Inc Commercial: Foresight SARS-CoV-2 IgM EIA Test Kit Method: Immunoassay Target: Antibody, IgM Format: Automated, 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