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