CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: A. Menarini Diagnostics | Commercial: ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Abbott Rapid Diagnostics | Commercial: Panbio COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co., Ltd | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd | Commercial: Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd | Commercial: COVID-19 RAPID IgG/IgM test kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Biotech (Hangzhou) Co., Ltd. | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: ACON SARS-CoV-2 IgG/IgM Rapid Test | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Flowflex SARS-CoV-2 Antigen rapid test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories, Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO Biotech | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 Antigen Rapid Test (For Reader) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 Antigen Test Cassette (For Analyzer) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 IgG Rapid Test | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 IgG/IgM Rapid Test Dipstick | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 IgG/IgM Test Cassette (for Analyzer) | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AEP Alliance (Taiwan)(AnTaimmu BioMed Co., Ltd, EirGenix, Inc and Panion & BF Biotech) | Commercial: COVID-19 Antigen Rapid Test (Vstrip) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AIDIAN | Commercial: Acro 2019-nCoV IgG/IgM pikatesti | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc | Commercial: DrivenFlow COVID-19 | Method: Immunoassay | Target: Antibody | 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: 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: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 Ag | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AmonMed Biotechnology Co., Ltd | Commercial: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AmonMed Biotechnology Co., Ltd | Commercial: COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AmonMed Biotechnology Co., Ltd | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AmonMed Xiamen Biotechnology Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMP Diagnostics (AMEDA Labordiagnostik GmbH) | Commercial: Rapid Test SARS-CoV-2 Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV Antigen Device | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV IgG/IgM Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anhui DeepBlue Medical Technology Co., Ltd | Commercial: COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD. | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: APLUS Diagnostics Laboratuvar San.Tic.A.S. | Commercial: SMARAPIDTEST | Method: Immunoassay | Target: Antibody, Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Apollo Biomedical LLC | Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) | 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: Artron Laboratories Inc | Commercial: COVID - 19 Antigen Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Artron Laboratories Inc. | Commercial: Artron COVID-19 IgM/IgG Antibody Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 IgG/IgM | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test Flu/COVID-19 Ag Combo | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 & Influenza A/B Antigen Combo Test Device | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 & M. pneumoniae Antigen Combo Test Device | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Device | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Antigen Saliva Test Kit | Method: Immunoassay | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Device | 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