Skip to main content
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
No ImmunoAssay-Antibody Nantong Diagnos Biotechnology (2019-n.CoV) New coronavirus Antibody Test (Colloidal Gold) Antibody Commercialized Go to details
Yes ImmunoAssay-Antibody Natejah (COVID-19) IgG/IgM Rapid Test IgG, IgM Rapid diagnostic test Commercialized Go to details
Yes ImmunoAssay-Antibody JinHuan Medical Instrument Co., Ltd  (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) IgG, IgM Rapid diagnostic test Commercialized Go to details
No NucleicAcid-PCR based Spectrum for Diagnostic Industries (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit Nucleic acid Manual NAT Commercialized Go to details
Yes ImmunoAssay-Antibody Shandong ThinkLab Biotechnology Co., Ltd  09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) IgG, IgM Manual or automated Commercialized Go to details
No ImmunoAssay-Antibody Biomeme 10 Minutes COVID-19 IgG/IgM Rapid Test IgG, IgM Rapid diagnostic test Commercialized Go to details
Yes NucleicAcid-PCR based 1drop Inc. 1copy™ COVID-19 qPCR Kit Nucleic acid Manual NAT Commercialized Go to details
Yes ImmunoAssay-Antibody Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019 nCOV IgG/IgM Rapid Test IgG, IgM Rapid diagnostic test Commercialized Go to details
No ImmunoAssay-Antibody Microtrace Diagnostici SRL 2019 NCOV IGG/IGM TEST IgG, IgM Commercialized Go to details
Yes ImmunoAssay-Antibody Edinburgh Genetics Limited  2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) IgG, IgM Rapid diagnostic test Commercialized Go to details
No NucleicAcid-PCR based Centers for Disease Control and Prevention 2019 nCoV Real-Time RT-PCR Diagnostic Panel Nucleic acid Manual NAT Commercialized Go to details
No NucleicAcid-PCR based Anitoa 2019 New Coronavirus (2019-nCoV) Test Kit Nucleic acid Manual or automated Commercialized Go to details
No ImmunoAssay-Antibody Guangzhou Darui Biotechnology Co.,Ltd  2019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method) IgG Manual or automated Commercialized Go to details
No ImmunoAssay-Antibody Guangzhou Darui Biotechnology Co.,Ltd 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) IgM Manual or automated Commercialized Go to details
No NucleicAcid-PCR based Guangzhou HEAS BioTech Co., Ltd  2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) Nucleic acid Manual NAT Commercialized Go to details
No NucleicAcid-PCR based Northwell Health 2019 Novel Coronavirus PCR Nucleic acid N.A. In development Go to details
Yes NucleicAcid-PCR based Kogene Biotech 2019 Novel Coronavirus Real-time PCR Kit Nucleic acid Manual NAT Commercialized Go to details
Yes ImmunoAssay-Antibody Hangzhou Singclean Medical Products Co., Ltd. (CN); Sungo Europe B. V. (NL) 2019-nCoV Ab Test (Colloidal Gold) IgG, IgM Rapid diagnostic test Commercialized Go to details
Yes ImmunoAssay-Antibody Innovita Biological Technology 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) IgG, IgM Rapid diagnostic test Commercialized Go to details
No NucleicAcid-PCR based Biosearch Technologies 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 Nucleic acid Commercialized Go to details
No NucleicAcid-PCR based Beijing Shengkun Kangru Medical Equipment Co., Ltd. 2019-nCoV Detection kit (quantum dot immunofluorescence method)  Nucleic acid Manual or automated In development Go to details
No NucleicAcid-PCR based Hangzhou Dan Wei Biotechnology Co.Ltd 2019-nCoV Direct RT-qPCR Kit Nucleic acid Manual NAT In development Go to details
Yes ImmunoAssay-Antibody AmonMed Biotechnology Co., Ltd  2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) Antibody Rapid diagnostic test Commercialized Go to details
Yes ImmunoAssay-Antibody Beijing Diagreat Biotechnologies Co., Ltd  2019-nCoV IgG Antibody Determination Kit IgG Rapid diagnostic test Commercialized Go to details
Yes ImmunoAssay-Antibody Dynamiker Biotechnology (Tianjin) Co., Ltd.  2019-nCOV IgG Antibody kit (ELISA) IgG Manual or automated Commercialized 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