| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid antibody (GTX135357)_ELISA | Device ID: 560 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) spike antibody (GTX135360)_ELISA | Device ID: 562 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 Antigen ELISA | Device ID: 2289 | Method: ELISA | Target: Antigen | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 Antigen ELISA Kit | Device ID: 140 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay) | Device ID: 1293 | Method: ELISA | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Yunrui Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Testing kit(Colloidal Gold) | Device ID: 2904 | Method: ELISA | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Proel Biotech Ltd. | Commercial: SARS-CoV-2 IgG antibody detection kit (ELISA) | Device ID: 1482 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgG ELISA | Device ID: 596 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 IgG ELISA Kit | Device ID: 138 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ideal Tashkhis Atieh Co. | Commercial: SARS-CoV-2 IgG ELISA Kit | Device ID: 571 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Viracor Eurofins | Commercial: SARS-CoV-2 IgG ELISA Test Kit | Device ID: 1622 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ideal Tashkhis Atieh Co. | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 659 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 139 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 597 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 NAb ELISA | Device ID: 2431 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 NeutraLISA | Device ID: 2751 | Method: ELISA | Target: Antibody, IgA, IgG, IgM | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Neutralization Antibody Test Kit (ELISA) | Device ID: 2338 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay (ELISA) | Device ID: 2216 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA) | Device ID: 1765 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biosino Bio-Technology and Science Inc. | Commercial: SARS-CoV-2 Neutralizing antibody Test Kit (ELISA) | Device ID: 2857 | Method: ELISA | Target: Antibody | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: UAB Imunodiagnostika | Commercial: SARS-CoV-2 S IgG ELISA | Device ID: 1740 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GenScript | Commercial: SARS-CoV-2 Spike S1-RBD IgG&IgM ELISA Detection Kit | Device ID: 1620 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: SARS-CoV-2 Total Ab | Device ID: 1050 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: SARS-CoV-2 Total Ab ELISA | Device ID: 833 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioMARIC | Commercial: SARS-CoV-2 Total Ab ELISA | Device ID: 2639 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-COV-2 Total Antibody ELISA Kit | Device ID: 137 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Total Antibody Test Kit (ELISA) | Device ID: 2337 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily) | Device ID: 874 | Method: ELISA | Target: Antibody, IgA, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: InBios International | Commercial: SCoV-2 Detect IgG ELISA | Device ID: 1409 | Method: ELISA | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: InBios International | Commercial: SCoV-2 Detect IgM ELISA | Device ID: 1410 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Viracor Eurofins | Commercial: SCoV-2 DetectTM IgM ELISA | Device ID: 1624 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgA | Device ID: 2747 | Method: ELISA | Target: IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgG | Device ID: 2745 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgM | Device ID: 2748 | Method: ELISA | Target: IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotechnology | Commercial: SeroCap Anti-SARS-CoV-2 Neutralizing Kit | Device ID: 2901 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Epigentek Group Inc. | Commercial: SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit | Device ID: 1044 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech Inc. | Commercial: SGT anti-SARS-CoV-2 total Ab ELISA | Device ID: 1113 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Solsten Diagnostics Intl. ApS | Commercial: Solsten SARS-CoV-2 Antigen ELISA Kit | Device ID: 2559 | Method: ELISA | Target: Antigen | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: STARK S.A.R.L | Commercial: Stark Portable COVID-19 Antigen Lab | Device ID: 2554 | Method: ELISA | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: United Biomedical | Commercial: UBI SARS-CoV-2 ELISA | Device ID: 698 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q COVID-19 IgG ELISA Kit | Device ID: 2789 | Method: ELISA | Target: IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q COVID-19 SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit | Device ID: 2790 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgA ELISA | Device ID: 1166 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgG ELISA | Device ID: 1164 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgM ELISA | Device ID: 1165 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: Wantai SARS-CoV-2 IgM ELISA | Device ID: 834 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co. Ltd. | Commercial: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) | Device ID: 1355 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Natejah | Commercial: (COVID-19) IgG/IgM Rapid Test | Device ID: 1019 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JinHuan Medical Instrument Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Device ID: 575 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) | Device ID: 1649 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, 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