| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: nCOV IgG/IgM Rapid Test | Device ID: 1078 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Kaya17 Inc. | Commercial: nCoVega Saliva-Based Rapid Antigen COVID19 Test | Device ID: 2779 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Module Innovations Private Ltd. | Commercial: nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual) | Device ID: 284 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Neisseria Gonorrhoeae Antigen Rapid Test Cassette | Device ID: 3139 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: NG-Test IgG-IgM COVID-19 | Device ID: 865 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Novatech | Commercial: NOVACHECK Diagnostic kit (collodial gold) for IgG/IgM Antibody to SARS-CoV-2 | Device ID: 1393 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgG | Device ID: 588 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgM | Device ID: 589 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa SARS-CoV-2 (COVID-19) | Device ID: 819 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: NovaLisa SARS-CoV-2 IgG assay | Device ID: 725 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing Novegent Biotech Company Limited | Commercial: Novegent COVID-19 Antibodies Rapid Test Kit | Device ID: 1185 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing Novegent Biotech Company Limited | Commercial: Novegent COVID-19 Antigen Rapid Test Kit | Device ID: 1189 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit | Device ID: 236 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Highcreation Technology Co. Ltd. | Commercial: Novel Corona- virus IgM/IgG Combo Rapid Test | Device ID: 1345 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing WSWY Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography) | Device ID: 1362 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) IgG / IgM Antibody Testing Kit (Colloidal Gold) | Device ID: 2515 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) | Device ID: 786 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit | Device ID: 452 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd. | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Device ID: 1785 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay) | Device ID: 2593 | Method: Immunoassay | Target: IgG, IgM | Format: Semi-automated | Go to details |
| CE Marking: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1639 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Quantum Dots Immunofluorescence) | Device ID: 1640 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Avioq Bio-Tech Co. Ltd. | Commercial: Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold) | Device ID: 47 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Detection Kit | Device ID: 2684 | Method: Immunoassay | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1784 | 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) | Device ID: 1828 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) - (saliva, sputum) | Device ID: 2634 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit (Colloidal Gold) | Device ID: 2514 | Method: Immunoassay | Target: Antibody | 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) | Device ID: 614 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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 | Device ID: 1743 | 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) - Saliva | Device ID: 1798 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV IgG Antibody Detection Kit (Colloidal Gold Method) | Device ID: 198 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV IgM Antibody Detection Kit (Colloidal Gold Method) | Device ID: 197 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: H-Guard | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Device ID: 1636 | 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) | Device ID: 432 | Method: Immunoassay | Target: Antibody, IgG | 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) | Device ID: 430 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Decombio Biotechnology | Commercial: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette | Device ID: 666 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Assay Reagent Kit | Device ID: 1802 | 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 Rapid Test Device | Device ID: 1896 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Deangel Biological Engineering Co. Ltd. | Commercial: Novel Coronavirus S Glycoprotein Detection Kit | Device ID: 1259 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MR Healthcare | Commercial: Novel Coronavirus(COVID-19) Test | Device ID: 1021 | 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 | Device ID: 444 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Apollo Biomedical LLC | Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) | Device ID: 1289 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bionote Inc. | Commercial: NowCheck COVID-19 Ag Test | Device ID: 1242 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: OJABIO SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method) | Device ID: 3045 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: One check 2019-nCoV IgG/IgM | Device ID: 1007 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: One Step SARS-nCoV2 (COVID-19) IgG/IgM test | Device ID: 676 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) | Device ID: 2590 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold) | Device ID: 190 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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