| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Gold - OZO SARS-CoV-2 IgG Method | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: Oy SARSPLEX | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPTI Medical Systems | Commercial: OPTI SARS-CoV-2 Total Antibody Test Kit | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: OPTI Medical Systems | Commercial: OPTI SARS-CoV-2 RT-PCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech, Inc | Commercial: OnSite COVID-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech | Commercial: OnSite COVID-19 Ag Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics, Inc | Commercial: OneStep COVID-19 Antigen RapiCard InstaTest | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: One check 2019-nCoV IgG/IgM | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hong Kong University of Science and Technology | Commercial: On-site rapid molecular diagnostic system based on Shenzhen Shineway Technology | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: OmniPATH COVID-19 Total Antibody ELISA Test | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: NxTAG CoV Extended Panel | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co.,Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit (Manual method) | Method: N.A. | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co., Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit | Method: | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc | Commercial: Nucleic Acid Detection Kit For COVID-19 (PCR Fluorescence Probe) | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: NuActor - Viral extraction kit | Method: Other | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bionote, Inc | Commercial: NowCheck COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Apollo Biomedical LLC | Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc | Commercial: Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Yuno Diagnostics Co., Ltd | Commercial: Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MR Healthcare | Commercial: Novel Coronavirus(COVID-19) Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: Novel Coronavirus(2019-nCov)RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Deangel Biological Engineering Co., Ltd | Commercial: Novel Coronavirus S Glycoprotein Detection Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel coronavirus neutralizing antibody Rapid Test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus Neutralizing Antibody Assay Reagent Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: Novel Coronavirus IgM antibody test kit (colloidal gold method) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: Novel Coronavirus IgG antibody test kit (colloidal gold method) | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: biocomma limited | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) CO., LTD | Commercial: Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Fluorescence PCR method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen rapid test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Outdo Biotech Co., Ltd | Commercial: Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shaanxi Lifegen Co., Ltd | Commercial: Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medakit | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Pharma | Commercial: Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Pharma | Commercial: Novel Coronavirus (2019-nCoV) Real-time Isothermal Amplification kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DAAN Gene Co., Ltd of Sun Yat-sen University | Commercial: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Biotechnology Co., Ltd | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co., Ltd | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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