| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: EUROFINS INGENASA | Commercial: INGEZIM COVID 19 SPIKE CROM | Device ID: 2458 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: SARS-CoV-2 Antigen | Device ID: 2457 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 Spike 1&2 IgG | Device ID: 2456 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 IgA | Device ID: 2455 | Method: ELISA | Target: IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asterion Otel Ä°nÅŸaat BiliÅŸim Medikal Maden Tic. Ltd. Åžti. | Commercial: As-check | Device ID: 2454 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dejavu Medikal San. Tic.Ldt.Åžti | Commercial: Dejavu COVİD-19 Antigen Rapit test (nazofaringeal/ orafaringel swap) | Device ID: 2453 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Device ID: 2452 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Device ID: 2451 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: SARS CoV 2 IgM/IgG Duo Test Kit (Colloidal Gold) | Device ID: 2450 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Rapid Test (Swab) | Device ID: 2449 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ADS Biotec Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Device ID: 2448 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) | Device ID: 2447 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genomtec SA | Commercial: SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit | Device ID: 2446 | Method: LAMP | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GVS S.p.A. | Commercial: Flame CoViD -19 VARIANTS qPCR Master Kit – CE-IVD | Device ID: 2445 | Method: RT-PCR | Target: | Format: Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Healthcare Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2444 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OACP IE Ltd. | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR Method) | Device ID: 2443 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: OACP IE Ltd. | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Device ID: 2442 | Method: RT-PCR | Target: | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2441 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2440 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2439 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2438 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2437 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2436 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2435 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2434 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2433 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) | Device ID: 2432 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: Anti-SARS-CoV-2 RBD ELISA | Device ID: 2430 | Method: ELISA | Target: Antibody | Format: Manual | 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: FUJIFILM Corporation | Commercial: FUJIFILM COVID-19 Ag Test | Device ID: 2428 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2427 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Avacta Life Sciences Ltd. | Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test | Device ID: 2426 | Method: | Target: Antigen | Format: | 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 Neutralizing Antibody ELISA Kit | Device ID: 2424 | Method: ELISA | Target: Antibody | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: MyBox Flurescence Immunoassay Analyzer | Device ID: 2423 | Method: Immunoassay | Target: Antigen | Format: Automated | 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: Shanghai Chuangkun Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV）RT-PCR Detection Kit (Lyophilized) | Device ID: 2421 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) Package Insert | Device ID: 2420 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen) | Device ID: 2419 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 antigen test kit (Saliva sample) | Device ID: 2418 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) | Device ID: 2417 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2416 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Sars-CoV-2 antigen test kit (colloidal gold) | Device ID: 2415 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2414 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Boditech Quick™ COIVD-19 Ag | Device ID: 2413 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2412 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2411 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2410 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2409 | Method: Immunoassay | Target: Antigen | 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