| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 （SARs-Cov-2）Antigen Rapid Test Kit (Nasal Swab) | Device ID: 2512 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 （SARs-Cov-2）Antigen Rapid Test Kit (Saliva) | Device ID: 2511 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Zhongsheng Langjie Biotechnology Co. Ltd. | Commercial: AgiAccu COVID-19 Antigen Test Cassette | Device ID: 2510 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Oropharyngeal swab) | Device ID: 2509 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vatic Health Ltd. | Commercial: KnowNow SARS-CoV-2 Rapid Antigen Test | Device ID: 2508 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Device ID: 2506 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co. Ltd. | Commercial: Canea COVID-19 Antigen Speichel Selbsttest | Device ID: 2505 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Nasopharyngeal Swab) | Device ID: 2504 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: BioSpeedia® Covid-19 Nasal AG test BSD_521 | Device ID: 2503 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VitroBioChem SRL | Commercial: Vitrotrack COVID-19 Antigen rapid test (swab) | Device ID: 2502 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd. | Commercial: Orawell COVID-19 Ag Rapid Saliva Test Device (CO-03) | Device ID: 2500 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cypress Diagnostics | Commercial: COVID-19 Ag Rapid Test | Device ID: 2499 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: 2019-nCoV Saliva Ag EASY TEST | Device ID: 2498 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: Sars_Cov_2 NEUTRALIZING ANTIBODY Rapid Test Cassette GCCOV(NAb)-402b | Device ID: 2497 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd. | Commercial: OraWell COVID-19 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage) | Device ID: 2496 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd. | Commercial: OraWell COVID-19 Ag.Rapid Saliva test DEVICE, CO-07(One Step) | Device ID: 2495 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Beijing O&D Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2494 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ COVID-19 (N, ORF1a) Detection Kit | Device ID: 2493 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Dixion SARS-CoV-2 Neutralizing antibody test kit | Device ID: 2492 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2（ COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) | Device ID: 2491 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd. | Commercial: Saliva Orawell Covid_19 Ag | Device ID: 2490 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Dixion Safetest SARS-CoV-2 Antigen Speichel Schnelltest | Device ID: 2489 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou TianLong Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method) | Device ID: 2488 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: Diagnostic kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) | Device ID: 2487 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Antibody Rapid Detection Kit（Colloidal Gold） | Device ID: 2486 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal Gold） | Device ID: 2485 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test | Device ID: 2484 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: POLY-DETECH RAPIDTECH | Commercial: SARS-CoV-2 antigen rapid test | Device ID: 2483 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Detection Kit (Colloidal Gold) | Device ID: 2482 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioGnost Ltd. | Commercial: CoviGnost AG test devices | Device ID: 2481 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Formaster Biosci Co. Ltd. | Commercial: New Coronavirus (COVID-19) Antigen Rapid Test (saliva) | Device ID: 2480 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 Spike/RBD Ab | Device ID: 2478 | 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: AXIOM Gesellschaft für Diagnostica und Biochemica mbH | Commercial: COVID-19 Antigen Saliva Test | Device ID: 2476 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: Whisting 2019-nCoV Saliva Ag EASY TEST | Device ID: 2475 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV IgG&IgM Antibody Rapid Test Kit | Device ID: 2474 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV Ag Rapid Test Kit | Device ID: 2473 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-CoV Ag Saliva Rapid Test Card | Device ID: 2470 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: FaStep COVID-19 Antigen Nasal Test Kit | Device ID: 2469 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: 2019-nCoV Rapid Antigen Test | Device ID: 2468 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Precision Biosensor | Commercial: PBCheck COVID-19 Ag | Device ID: 2467 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: VZV DNA QUANTITATION (QT) | Device ID: 2466 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: C4Diagnostics | Commercial: C4Covid-19 Human | Device ID: 2465 | Method: LAMP | Target: Nucleic acid | Format: Manual | 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 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: ACE2-RBD Neutralization Assay | Device ID: 2462 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 IgG/IgM Confirmation and Typing | Device ID: 2461 | Method: ELISA | Target: IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 RNA Vs 2 | Device ID: 2460 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Acura Kliniken Baden-Baden GmbH | Commercial: Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit | Device ID: 2459 | Method: Immunochromatography | Target: Antibody, Antigen | Format: Manual | 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