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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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2888 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Koch Biotechnology (Beijing) Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Kit Device ID: 2038 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 Antigen Saliva Test Kit Device ID: 2037 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: BioMaxima SA Commercial: COVID-19 Antigen Rapid Test Device ID: 2036 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: BioMaxima SA Commercial: SARS-CoV-2 Ag Rapid Test Device ID: 2035 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biopanda Reagents Commercial: COVID-19 Rapid Antigen Test Device ID: 2034 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BTNX Inc. Commercial: Rapid Response COVID-19 IgG/IgM Rapid Test Device Device ID: 2033 Method: Immunochromatography Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: EON Biotechnology Limited Commercial: EONBT COVID-19 Antigen Device ID: 2032 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. Commercial: Coronavirus Ag Rapid Test Cassette (Swab) Device ID: 2031 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette (saliva) Device ID: 2030 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Device ID: 2029 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SG Diagnostics Commercial: SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody) Device ID: 2028 Method: Immunochromatography Target: Antibody, IgG Format: Manual Go to details
CE Marking: Yes Manufacturer: MultiplexDX s.r.o. Commercial: rTEST COVID-19 qPCR Allplex Device ID: 2027 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Reagent Technology Co. Ltd. Commercial: SARS-CoV-2 antigen IVD kit SWAB Device ID: 2026 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Siemens Healthineers Commercial: Dimension Vista SARS-CoV-2 IgG (CV2G) Device ID: 2025 Method: Immunoassay Target: IgG Format: Lab-based, Other Go to details
CE Marking: Yes Manufacturer: Siemens Healthineers Commercial: ADVIA Centaur XP/XPT SARS-CoV-2 IgG (sCOVG) Device ID: 2024 Method: Immunoassay Target: IgG Format: Lab-based, Other Go to details
CE Marking: Yes Manufacturer: Siemens Healthineers Commercial: Atellica IM SARS-CoV-2 IgG (sCOVG) Device ID: 2023 Method: Immunoassay Target: Antibody, IgG Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Siemens Healthineers Commercial: ADVIA Centaur CP SARS-CoV-2 IgG (sCOVG) Device ID: 2022 Method: Immunoassay Target: Antibody, IgG Format: Lab-based, Other Go to details
CE Marking: Yes Manufacturer: Ningbo Home Test Bio-echnology Co. Ltd. Commercial: SARS-oV- Antigen Rapid Test kit (Saliva Test) Device ID: 2021 Method: Chromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Addbio Meditek Co. Commercial: AddMedi SARS-CoV-2 RT-qPCR Kit Device ID: 2020 Method: RT-PCR Target: Nucleic acid Format: Automated Go to details
CE Marking: Yes Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) Device ID: 2019 Method: RT-PCR Target: Nucleic acid Format: Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co. Ltd. Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) Device ID: 2018 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Ultra-Diagnostics Biotec. Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit Device ID: 2017 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Siemens Healthineers Commercial: ADVIA Centaur XP/XPT SARS-CoV-2 Antigen (CoV2Ag) Device ID: 2016 Method: Immunoassay Target: Antigen Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Siemens Healthineers Commercial: Atellica IM SARS-CoV-2 Antigen (CoV2Ag) Device ID: 2015 Method: Immunoassay Target: Antigen Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Immundiagnostik AG Commercial: MutaPLEX® Coronavirus Real-Time-RT-PCR-Kit Device ID: 2014 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Biotical Health S.L.U. Commercial: biotical SARS-CoV-2 Ag Card Device ID: 2013 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Genrui Biotech Inc. Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Device ID: 2012 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Link Technology Co. Ltd. Commercial: NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Device ID: 2010 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Zhengzhou Fortune Bioscience Co. Ltd. Commercial: COVISTIX COVID-19 VIRUS Rapid Antigen Detection Test Device ID: 2009 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. Commercial: AndLucky SARS CoV-2 Antigen Rapid Test, Anterior Nasal Check (minimal-invasiv) Device ID: 2008 Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: DyonMed SA Commercial: SieloCovidAg Device ID: 2007 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Jiangsu Medomics medical technology Co. Ltd. Commercial: SARS-CoV-2 antigen Test Kit (LFIA) Device ID: 2006 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Plexense Inc. Commercial: ACCEL ELISA COVID-19 kit Device ID: 2005 Method: ELISA Target: Antibody, IgA, IgG, IgM Format: Manual, Semi-automated Go to details
CE Marking: Yes Manufacturer: bioMérieux SA Commercial: SARS-COV-2 RESPI R-GENE Device ID: 2004 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: SG Diagnostics Pte Ltd. Commercial: SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) Device ID: 2003 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Coris BioConcept Commercial: COVID-19 Sero NP/RBD Device ID: 2002 Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Genomtec SA Commercial: GenomtecSARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit Device ID: 2000 Method: LAMP Target: Nucleic acid Format: Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: CAMP MEDICA DISTRIBUTION Commercial: See Now Coronavirus nCoV antigen test Device ID: 1999 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Dakewe Bio-engineering Co. Ltd. Commercial: COVID-19 IgM/IgG Rapid Test Kit Device ID: 1998 Method: Immunochromatography Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Xiamen Hopegen Medical Technology Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 1996 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Dakewe Bio-engineering Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Kit Device ID: 1995 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) Device ID: 1994 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: STAB VIDA Commercial: Dr Vida pocket for COVID-19 Device ID: 1993 Method: LAMP Target: Nucleic acid Format: Near POC / POC, Other Go to details
CE Marking: Yes Manufacturer: Abingdon Health Plc Commercial: AbC-19 Rapid Test Device ID: 1992 Method: Immunoassay Target: IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biozek Medical Commercial: COVID-19 Antigen Rapid Test Cassette (Oral Fluid) Device ID: 1991 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc. Commercial: ichroma™ COVID-19 Ag Device ID: 1990 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc. Commercial: AFIAS COVID-19 Ag Device ID: 1989 Method: Immunoassay Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Inzek International trading Commercial: Biozek covid-19 Antigen Rapidtest BCOV-502 Device ID: 1988 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Inzek International trading Commercial: Biozek covid-19 Antigen Rapidtest BCOV-802 Device ID: 1987 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Diasia Biomedical Technology Co. Ltd. Commercial: SARA-CoV-2 Antigen Rapid Test Kit Device ID: 1986 Method: Immunoassay Target: Antigen Format: 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