| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| 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 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: 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: MR Healthcare | Commercial: Novel Coronavirus(COVID-19) Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: 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: 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: Mobidiag | Commercial: Novodiag COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Boditech Med Inc | Commercial: NuActor - Viral extraction kit | Method: Other | Target: Nucleic acid | Format: Automated, Manual | 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: Beijing Lepu Medical Technology Co., Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit | Method: | Target: | Format: Automated | 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: Luminex Corp. | Commercial: NxTAG CoV Extended Panel | 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: 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: 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: 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: 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: CTK Biotech | Commercial: OnSite COVID-19 Ag Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: 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: 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: Tezted | Commercial: Oy SARSPLEX | 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: 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 Silver - OZO SARS-CoV-2 IgM Method | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Rapid Diagnostics | Commercial: Panbio COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest de Coronavirus IgM/IgG 2019-n-CoV | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PaxGen Bio Co. Ltd | Commercial: PaxView COVID-19 real time RT-PCR | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Gold | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Rapid FIA | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 IgG/IgM Rapid Gold | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCLMD nCoV one step RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PEPperPRINT GmbH | Commercial: PEPperCHIP SARS-CoV-2 Proteome Microarray (manual) | Method: Other | Target: Other | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc | Commercial: PerkinElmer New Coronavirus Nucleic Acid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc | Commercial: PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Procomcure Biotech GmbH | Commercial: PhoenixDx SARS-Cov-2 IVD | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bio-Rad Laboratories, Inc | Commercial: Platelia SARS-CoV-2 Total Ab Assay | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: PowerChek 2019-nCoV Real-time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AZZ | Commercial: PRESTO 2019-nCoV Direct qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab S.A. | Commercial: PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Promotor SARS-CoV-2 RT-PCR Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Promotor SARS-CoV-2 RT-PCR Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: JN Medsys | Commercial: ProTect Covid-19 RT-qPCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: qCOVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: QIAGEN GmbH | Commercial: QIAstat-Dx Respiratory Panel 2019-nCoV | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Vitassay | Commercial: qPCR SARS-CoV-2 (test description in spanish and english) | 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