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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
No NucleicAcid-PCR based Landcent Europe B.V. Real time RT-PCR Kit for the detection of SARS-CoV-2 Nucleic acid Manual NAT In development Go to details
No ImmunoAssay-Antigen Leadgene Biomedical, Inc.  Leadgene® SARS/SARS-CoV-2 Antigen Rapid Test Kit Antigen Rapid diagnostic test In development Go to details
No NucleicAcid-PCR based AnyGenes  Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) Nucleic acid Rapid diagnostic test Commercialized Go to details
No ImmunoAssay-Antibody Leadgene Biomedical, Inc.  Leadgene® SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit IgG, IgM Rapid diagnostic test In development Go to details
No Others Assure Tech. (Hangzhou) Co., Ltd COVID-19 Antigen Rapid Test Device  Other Rapid diagnostic test In development Go to details
No NucleicAcid-PCR based 3B BlackBio Biotech India Ltd TRUPCR®SARS-CoV-2 RT qPCR Kit  Nucleic acid Manual NAT Commercialized Go to details
No ImmunoAssay-Antibody Lifeassay Diagnostics Pty Ltd  Test-it COVID-19 IgM/IgG Lateral Flow Assay IgG, IgM Rapid diagnostic test In development Go to details
No NucleicAcid-PCR based Aura Biotechnologies Ltd  Quick COVID-19 Colorimetric LAMP PCR Nucleic acid Manual NAT In development Go to details
No NucleicAcid-PCR based Aura Biotechnologies Ltd  Quick COVID-19 Realtime Multiplex PCR Nucleic acid Manual NAT In development Go to details
No NucleicAcid-PCR based Becton Dickinson  BioGX SARS-CoV-2 Reagents for BD MAX™ System Nucleic acid Automated lab-based, near-POC NAT or POC NAT Commercialized Go to details
No ImmunoAssay-Antibody Tersaco AG SARS CoV-2 IgG/IgM Rapid Test IgG, IgM Rapid diagnostic test Commercialized Go to details
No ImmunoAssay-Antibody Axium Bioresearch Inc.  AxiumHealth COVID-19 IgG/IgM Antibody Test  IgG, IgM Commercialized Go to details
No ImmunoAssay-Antibody Biogate Laboratories Ltd  COVID-19 IgG/IgM Ab Rapid Test  IgG, IgM Rapid diagnostic test Commercialized Go to details
No ImmunoAssay-Antibody Abbott BasePoint Covid-19 IgG/IgM Rapid test Device IgG, IgM Rapid diagnostic test Commercialized Go to details
No ImmunoAssay-Antibody Absea Biotechnology Ltd, The non-invasive MEGA test of SARS-CoV-2 Antibody Rapid diagnostic test In development Go to details
No ImmunoAssay-Antibody Biogenix Inc. Pvt Ltd.  SARS CoV-2 IgG/IgM Ab Rapid Test IgG, IgM Rapid diagnostic test Commercialized Go to details
No ImmunoAssay-Antigen Abwiz Bio RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) Antigen Manual or automated In development Go to details
No ImmunoAssay-Antibody Academia Sinica Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit IgG, IgM Rapid diagnostic test In development Go to details
No ImmunoAssay-Antigen Luminostics, Inc.  CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) Antigen Rapid diagnostic test In development Go to details
No ImmunoAssay-Antigen Academia Sinica SARS-CoV-2 Nucleocapsid Protein Rapid Detection Kit Antigen Rapid diagnostic test In development Go to details
No ImmunoAssay-Antibody Denka Seiken Co. Ltd  QuickNavi-COVID19  In development Go to details
No ImmunoAssay-Antibody Assut Europe Covid-19 IgG/IgM RAPID TEST IgG, IgM Rapid diagnostic test Commercialized Go to details
No NucleicAcid-PCR based A*ccelerate A*STAR Fortitude Kit 2.0 (Singapore HSA) – PCR kit Nucleic acid Manual NAT Commercialized Go to details
No ImmunoAssay-Antibody Artron Laboratories One Step Novel Coronavirus (COVID-19) IgM/IgG Antibody Test Kit IgG, IgM Rapid diagnostic test Commercialized Go to details
No NucleicAcid-PCR based EMG  Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO) Nucleic acid 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