| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Platelia SARS-CoV-2 Total Ab Assay | Device ID: 756 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Viola Diagnostics Systems-Tulip Diagnostics | Commercial: PerkinElmer® COVID-19 Antigen Test | Device ID: 3147 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Diagnostics | Commercial: PerkinElmer COVID-19 Antigen Test (NS,NP) | Device ID: 2687 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 1264 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc. | Commercial: Pelican COVID-19 Ultra-Rapid Mobile Test | Device ID: 2283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 IgG/IgM Rapid Gold | Device ID: 307 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 Ag Rapid FIA | Device ID: 308 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Neutralizing Antibody Lateral Flow Test Kit | Device ID: 2425 | Method: Immunoassay | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Lateral Flow Test Device | Device ID: 2408 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Fluorescence Immunoassay Kit | Device ID: 2422 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Ag Lateral Flow Test Device | Device ID: 2320 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest de Coronavirus IgM/IgG 2019-n-CoV | Device ID: 1003 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag | Device ID: 1270 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Silver - OZO SARS-CoV-2 IgM Method | Device ID: 476 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Gold - OZO SARS-CoV-2 IgG Method | Device ID: 475 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method | Device ID: 474 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: Oy SARSPLEX | Device ID: 811 | 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 | Device ID: 1422 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 IgG/IgM Rapid Test | Device ID: 902 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 Ag Rapid Test | Device ID: 1581 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: OneStep COVID-19 Antigen RapiCard InstaTest | Device ID: 1195 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Total Antibody /Neutralizing Antibody (Colloidal Gold) | Device ID: 2589 | Method: Immunoassay | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Device ID: 2183 | 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 |
| 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 |
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