| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 2704 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co. Ltd. | Commercial: SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method | Device ID: 616 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method) | Device ID: 1757 | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Bioworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography )-Lollipop style | Device ID: 3090 | Method: Chromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Bioworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 3089 | Method: Chromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 2705 | Method: Chromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ningbo Home Test Bio-echnology Co. Ltd. | Commercial: SARS-oV- Antigen Rapid Test kit (Saliva Test) | Device ID: 2021 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vision Biyotenoloji Ar-Ge Lab Sist. San. Ve Tic. Ltd. ÅžTÄ° | Commercial: VISION® COVID-19 AG RAPID TEST | Device ID: 2836 | Method: Chromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vision Biyotenoloji Ar-Ge Lab Sist. San. Ve Tic. Ltd. ÅžTÄ° | Commercial: VISION® SARS-COV-2 AG RAPID NASOPHARYNGEAL TEST KIT | Device ID: 2835 | Method: Chromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG | Device ID: 2996 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG (1st IS) | Device ID: 2994 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG II | Device ID: 2995 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgM | Device ID: 2997 | Method: CLIA | Target: IgM | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: Anti-SARS-CoV-2 RBD CLIA Microparticles | Device ID: 2429 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 ACE2-RBD NEUTRALIZATION | Device ID: 2479 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgA | Device ID: 2477 | Method: CLIA | Target: IgA | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgG | Device ID: 2463 | Method: CLIA | Target: Antibody, IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgM | Device ID: 2464 | Method: CLIA | Target: IgM | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 Spike/RBD Ab | Device ID: 2478 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit | Device ID: 1416 | Method: CLIA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: Elecsys® SARS-CoV-2 Antigen | Device ID: 2156 | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON® SARS-CoV-2 Ag | Device ID: 1960 | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 Ag (CLIA) | Device ID: 2187 | Method: CLIA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) | Device ID: 1491 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) | Device ID: 1299 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 AntigenTest | Device ID: 1612 | Method: CLIA | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antibody Assay (CLIA) | Device ID: 2213 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgG (Chemiluminescent Immunoassay) | Device ID: 2042 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 IgG (CLIA) | Device ID: 1709 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay) | Device ID: 2753 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Autobio Diagnostics Co. Ltd. | Commercial: SARS-CoV-2 IgG II CLIA Microparticles | Device ID: 919 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgM (Chemiluminescent Immunoassay) | Device ID: 2043 | Method: CLIA | Target: Antibody, IgM | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 IgM (CLIA) | Device ID: 1710 | Method: CLIA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 NAbs (CLIA) | Device ID: 1708 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay (CLIA) | Device ID: 2212 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (MCLIA) | Device ID: 4002 | Method: CLIA | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) | Device ID: 1071 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TECHNOGENETICS | Commercial: TGS COVID-19 IgG | Device ID: 2770 | Method: CLIA | Target: IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: TECHNOGENETICS | Commercial: TGS COVID-19 IgM | Device ID: 2771 | Method: CLIA | Target: IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ortho Clinical Diagnostics | Commercial: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG | Device ID: 795 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ortho Clinical Diagnostics | Commercial: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total | Device ID: 590 | Method: CLIA | Target: Antibody, IgA, IgG, IgM | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ortho Clinical Diagnostics | Commercial: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen | Device ID: 1200 | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | Go to details |
| CE Marking: No | Manufacturer: MGI Tech Co. Ltd. | Commercial: Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation | Device ID: 483 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARs-CoV-2 CRISPR | Device ID: 2717 | Method: CRISPR | Target: | Format: | Go to details |
| CE Marking: No | Manufacturer: Caspr Biotech | Commercial: Phantom 1.0 Dx (near POC) | Device ID: 115 | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sherlock Biosciences | Commercial: Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens | Device ID: 645 | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mammoth Biosciences | Commercial: SARS-CoV-2 DETECTR | Device ID: 273 | Method: CRISPR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sherlock Biosciences | Commercial: Sherlock CRISPR SARS-CoV-2 | Device ID: 372 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: JRC | Commercial: Test.11.12.2024 | Device ID: 25665 | Method: CRISPR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: No | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Bio-Rad SARS CoV-2 ddPCR Assay | Device ID: 541 | Method: Digital-PCR | Target: Nucleic acid | 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