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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

CE Marking Detection Principle Manufacturer Commercial Name Target Format Commercial Status Navigate
Yes NucleicAcid-PCR based AniCon Labor GmbH  Kylt® SARS-CoV-2 Screening RTU RT-qPCR Nucleic acid Manual NAT Commercialised Go to details
Yes ImmunoAssay-Antigen ArcDia International Ltd  mariPOC SARS-CoV-2  Antigen Automated lab-based, near-POC NAT or POC NAT Commercialised Go to details
Yes ImmunoAssay-Antibody Technogenetics SRL RAPID TEST SARS-CoV-2 IgM/IgG GOLD IgG, IgM Rapid diagnostic test Commercialised Go to details
Yes ImmunoAssay-Antigen AMS UK (NI) Ltd COVID-19 Antigen ELISA Antigen Manual or automated Commercialised Go to details
Yes NucleicAcid-PCR based 1drop Inc. 1copy™ COVID-19 qPCR Kit Nucleic acid Manual NAT Commercialised Go to details
Yes ImmunoAssay-Antibody Prima Professional COVID-19 IgG/IgM Rapid Test IgG, IgM Rapid diagnostic test Commercialised Go to details
Yes ImmunoAssay-Antigen Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) Antigen Rapid diagnostic test Commercialised Go to details
Yes NucleicAcid-PCR based 3D Medicines 2019-nCoV RT-qPCR Nucleic acid Automated lab-based, near-POC NAT or POC NAT Commercialised Go to details
Yes NucleicAcid-PCR based Appolon Bioteck  Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) Nucleic acid Automated lab-based, near-POC NAT or POC NAT Commercialised Go to details
Yes ImmunoAssay-Antibody Tregena 3gamma COVID-19 IgA / IgM / IgG IgA, IgG, IgM Rapid diagnostic test Commercialised Go to details
Yes ImmunoAssay-Antigen Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (ELISA) Antigen Manual or automated Commercialised Go to details
Yes ImmunoAssay-Antibody Atlas Medical Atlas COVID-19 IgG/IgM Test Cassette IgG, IgM Rapid diagnostic test Commercialised Go to details
Yes ImmunoAssay-Antibody Atlas Medical Atlas COVID-19 Total Antibody Elisa Kit IgG, IgM Manual or automated Commercialised Go to details
Yes ImmunoAssay-Antibody Well Biotech COVID-19 IgM/IgG Rapid Test (Colloidal Gold) IgG, IgM Rapid diagnostic test Commercialised Go to details
Yes ImmunoAssay-Antigen Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) Antigen Rapid diagnostic test Commercialised Go to details
Yes NucleicAcid-PCR based 3D Medicines 3DMed 2019-nCoV RT-qPCR Detection Kit Nucleic acid Manual NAT Commercialised Go to details
Yes NucleicAcid-PCR based Liferiver Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit  Nucleic acid Manual NAT Commercialised Go to details
Yes ImmunoAssay-Antibody Atlas Medical Atlas COVID-19 S1-RBD IgG Elisa Kit IgG Manual or automated Commercialised Go to details
Yes ImmunoAssay-Antigen Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Antigen Rapid diagnostic test Commercialised Go to details
Yes NucleicAcid-PCR based AB ANALITICA Srl REALQUALITY RQ-2019-nCoV Nucleic acid Manual NAT Commercialised Go to details
Yes ImmunoAssay-Antibody Atlas Medical Atlas COVID-19 IgM Elisa Kit  IgM Manual or automated Commercialised Go to details
Yes ImmunoAssay-Antibody Newbury Pharmaceuticals S.A COVID-19 Coronavirus Rapid Test Kit IgG, IgM Rapid diagnostic test Commercialised Go to details
Yes ImmunoAssay-Antigen Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) Antigen Rapid diagnostic test Commercialised Go to details
Yes NucleicAcid-PCR based Liming Bio-Products Co., Ltd SrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit  Nucleic acid Manual NAT Commercialised Go to details
Yes NucleicAcid-PCR based Atlas Medical Atlas COVID-19 Real Time RT-PCR Kit  Nucleic acid Manual NAT Commercialised 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