| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39504-Recombinant SARS-CoV-2 Envelope Protein | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39505-Recombinant SARS-CoV (2004) Nucleocapsid Protein | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39506-Recombinant MERS-CoV Nucleocapsid Protein | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39507-Recombinant Influenza A and B Ha Protein | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39508R-Sengenics Respiratory Virus Protein Microarray | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Mediclone Biotech Pvt Ltd | Commercial: @sight COVID-19 IgG/IgM Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV- IgG/IgM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV-2 Ab | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eachy Biopharmaceuticals | Commercial: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: ACE2 antibody [N1N2], N-term (GTX101395) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgG | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: AFIAS COVID-19 Ab, IgM/IgG | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AlphaBiolabs | Commercial: AlphaBiolabs IgM-IgG Combined Antibody Rapid Test | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Labtest Diagnostica | Commercial: ANTI COVID-19 IGG/IGM RAPID TEST | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: H&Z Life Science Co. Ltd | Commercial: Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: RPC Diagnostic Systems | Commercial: Anti-SARS-CoV-2 enzyme immunoassay for the detection of antibodies to SARS-CoV-2 (COVID-19) | Method: Immunoassay | Target: Antibody | Format: Automated, 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: Autobio Diagnostics Co., Ltd | Commercial: Anti-SARS-CoV-2 Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: ASSURE SARS-CoV-2 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical | Commercial: Atlas COVID-19 Total Antibody Elisa Kit | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Axium Bioresearch Inc | Commercial: AxiumHealth COVID-19 IgG/IgM Antibody Test | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Baiya Phytopharm, Co., Ltd | Commercial: Baiya Rapid COVID-19 IgM/IgG test kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCoV IgG | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov Total Ig | Method: Immunoassay | Target: Antibody | Format: Automated, 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: Zhengzhou Humanwell Biocell Biotechnology Co., Ltd | Commercial: BIOCELL COVID-19 IgG ELISA test | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhengzhou Humanwell Biocell Biotechnology Co., Ltd | Commercial: BIOCELL COVID-19 IgM ELISA test | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: RapiGEN Inc | Commercial: BIOCREDIT COVID-19 IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc | Commercial: BIOCREDIT COVID-19 IgG+IgM Duo | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Rapigen Inc. | Commercial: BIOCREDIT COVID-19 IgG/IgM Combo | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nanjing BioPoint Diagnostics | Commercial: BioPoint SARS-CoV-2 dIgA/total antibody rapid test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX SWISS SA | Commercial: BIOSYNEX COVID-19 BSS | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Camtech Diagnostics Pte Ltd | Commercial: Camtech COVID-19 Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Wells Bio, Inc | Commercial: careUS COVID-19 IgM/IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: servoprax GmbH | Commercial: Cleartest Corona, Covid-19 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: Clungene COVID-19 IgM/IgG Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Fenghua Bioengineering , Co. LTD | Commercial: Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Applied Biomedical, LLC | Commercial: Confidence COVID-19 Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co.,Ltd | Commercial: Coretests COVID-19 Neutralizing Ab Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PZ CORMAY S.A. | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: CoronaCide | Commercial: CoronaCide | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RayBiotech | Commercial: Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd | Commercial: Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd | Commercial: Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing O&D Biotech | Commercial: Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Lab-based | 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