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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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53 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex Anti-SARS-CoV-2 S Antibody Rapid Test Device ID: 2951 Method: Immunochromatography Target: Antibody Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test Device ID: 4054 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Device ID: 1457 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Nasopharyngeal/Saliva) Device ID: 4057 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) Device ID: 1865 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva) Device ID: 4050 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim Device ID: 4053 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing) Device ID: 4052 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing) Device ID: 4051 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: ACON Laboratories Inc. Commercial: Flowflex SARS-CoV-2 Antigen rapid test Device ID: 1468 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Alfa Scientific Designs Inc. Commercial: DrivenFlow COVID-19 Device ID: 21 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Avacta Life Sciences Ltd. Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test Device ID: 2426 Method: Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method) Device ID: 3065 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) Device ID: 77 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Changsha Sanji Bio-technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Method) Device ID: 2990 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 Device ID: 1585 Method: Immunoassay Target: Antigen Format: Near POC / POC 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: Guangzhou Dongsheng Biotech Co. Ltd. Commercial: SARS-CoV-2 Antigen Test (Lateral Flow Method) Device ID: 3094 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: 2019-nCoV Antigen Test (Lateral Flow Method) Device ID: 3991 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: 2019-nCoV Antigen Test (Lateral Flow Method) Device ID: 3607 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: 2019-nCoV Antigen Test (Lateral Flow Method) - Nasal and Saliva Device ID: 3992 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) 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 (Lateral Flow Method) Device ID: 1213 Method: Immunoassay Target: Antibody, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: H&Z Life Science Co. Ltd. Commercial: Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay) Device ID: 1172 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: LT Biotech JSC Commercial: COVID19AgLTFLOW Device ID: 2094 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Medikit Commercial: MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay) Device ID: 796 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Medusa19 Life Sciences Commercial: MeduFlow Device ID: 2905 Method: Immunoassay Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Microgen Bioproducts Ltd. Commercial: Pathflow COVID 19 Rapid Antigen Pro (Swab) Device ID: 2782 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: Mylab Discovery Solutions Pvt. Ltd. Commercial: CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test Device ID: 2343 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Mylab Discovery Solutions Pvt. Ltd. Commercial: PathoCatch COVID-19 Ag Lateral Flow Test Device Device ID: 2320 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Mylab Discovery Solutions Pvt. Ltd. Commercial: PathoCatch COVID-19 Antigen Lateral Flow Test Device Device ID: 2408 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Mylab Discovery Solutions Pvt. Ltd. Commercial: PathoCatch COVID-19 Neutralizing Antibody Lateral Flow Test Kit Device ID: 2425 Method: Immunoassay Target: Antibody Format: Lab-based, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sensiva Health LLC Commercial: Sensiva Health React Rapid Antigen Test (Lateral Flow Method) Device ID: 2611 Method: Immunoassay Target: IgG, Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shanghai Liangrun Biomedicine Technology Co. Ltd. Commercial: LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) Device ID: 2155 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shanghai Liangrun Biomedicine Technology Co. Ltd. Commercial: LionRun™️SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay) Device ID: 1863 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. Commercial: SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method) (Nasal swab) Device ID: 3104 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. Commercial: SARS-CoV-2( COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method) Device ID: 2491 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. Commercial: SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method) Device ID: 2145 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen AIVD Biotech Inc. Commercial: SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay) Device ID: 2834 Method: Other Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Biocup Biotech Co. Ltd. Commercial: SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay) Device ID: 1950 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay) Device ID: 2166 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sona Nanotech Commercial: Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein Device ID: 502 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Synbiotik Biotechnology Commercial: Q-Check Rapid Lateral Flow Assay for SARS-CoV-2 Antigen Detection Device ID: 2884 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Tianjin Era Biology Technology Co. Ltd. Commercial: COVID-19 IgM/IgG Lateral Flow Assay Device ID: 624 Method: Immunoassay Target: Antibody, IgG, IgM 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