| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Amoy Diagnostics Co., Ltd | Commercial: AmoyDx Novel Coronavirus (2019 nCoV) Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen GmbH | Commercial: ampliCube Coronavirus Panel | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen GmbH | Commercial: ampliCube Coronavirus SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vircell S.L. | Commercial: AMPLIRUN CORONAVIRUS SARS (2003) RNA CONTROL | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vircell S.L. | Commercial: AMPLIRUN SARS-CoV-2 RNA CONTROL | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vircell S.L. | Commercial: AMPLIRUN TOTAL SARS-CoV-2 CONTROL (SWAB) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amplicon Ltd | Commercial: AmpliTest SARS-CoV-2 (Real Time PCR) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd. | Commercial: AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgA ELISA | Method: ELISA | Target: Antibody, IgA | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co., Ltd | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangxi YeLi Medical | Commercial: Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: AQ-TOP COVID-9 Rapid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech, Inc | Commercial: Aridia COVID-19 Real Time PCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 IgG/IgM | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test Flu/COVID-19 Ag Combo | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atila BioSystems, Inc | Commercial: Atila iAMP COVID-2019 Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ativa Medical | Commercial: Ativa Enhanced Screen | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical | Commercial: Atlas COVID-19 Real Time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Fjord Diagnostics SDN | Commercial: BHD SEDIPREP COVID-19 | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioeksen R&D Technologies Ltd | Commercial: Bio-Speedy Direct RT-qPCR SARS-CoV-2 | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: Biocard Covid-19 Rapid Test | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio, Inc | Commercial: careGENE COVID-19 RT-PCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio, Inc | Commercial: careGENE N-CoV RT-PCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Access Bio, Inc | Commercial: CareStart COVID-19 MDx RT-PCR | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: ChromaCode | Commercial: ChromaCode COVID-19 Six Target Single Well Assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: CLART COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biotech & Biomedicine (Shenyang) Group Ltd | Commercial: Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PZ CORMAY S.A. | Commercial: CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co.,Ltd | Commercial: Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OACP S.R.L. | Commercial: Corona Virus Disease 2019 (CoViD-19) Nucleic Acid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Ab IgG / IgM - Nucleocapsid (N protein) | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Antigen - Oral Fluid | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Antigen - Swab Specimen | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Process Engineering, Chinese Academy of Sciences | Commercial: Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuxi Shenrui Bio-pharmaceuticals Co. Ltd | Commercial: Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Device | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc | Commercial: COVID-19 Antigen Rapid Test Device | Method: | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc | Commercial: COVID-19 Antigen Saliva Test Kit | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioperfectus Technologies Co. Ltd (Jiangsu) | Commercial: COVID-19 Coronavirus Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR Solutions | Commercial: CoVID-19 dtec-RT-qPCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR solutions; Genetic Analysis Strategies S.L. | Commercial: CoVID-19 dtec-RT-qPCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc | Commercial: COVID-19 IgG/IgM Rapid Test Device | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Luxus Lebenswelt GMBH (Beijing NaGene Diagnosis Reagent Co., Ltd) | Commercial: COVID-19 mouth and throat Swab | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: STILLA | Commercial: COVID-19 Multiplex Crystal Digital PCR detection kit | Method: Digital-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Funuo Biomedical Co., Ltd | Commercial: COVID-19 Multiplex Fluorescent PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc | Commercial: COVID-19 Neutralizing Antibody FIA | Method: Other | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd | Commercial: COVID-19 Nucleic Acid Detection Kit (Multiplex Real Time PCR) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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