| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 ELISA IgM+IgA | Device ID: 423 | Method: ELISA | Target: Antibody, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 VIRCLIA IgM+IgA MONOTEST | Device ID: 424 | Method: Immunoassay | Target: Antibody, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 ELISA IgG | Device ID: 425 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: SARS-COV-2 REALTIME PCR KIT | Device ID: 426 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vitassay | Commercial: Vitassay qPCR SARS-CoV-2 | Device ID: 427 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd | Commercial: VivaDiag COVID-19 IgM/IgG Rapid Test | Device ID: 428 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: Novel Coronavirus IgM antibody test kit (colloidal gold method) | Device ID: 430 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: SARS-CoV-2 nucleic acid test kit | Device ID: 431 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: Novel Coronavirus IgG antibody test kit (colloidal gold method) | Device ID: 432 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd. | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Device ID: 435 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuxi Shenrui Bio-pharmaceuticals Co. Ltd | Commercial: Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection | Device ID: 436 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xi'an Goldmag Nanobio Tech Co., Ltd | Commercial: Real-Time RT-PCR assays for the detection of SARS-CoV-2 | Device ID: 437 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit | Device ID: 438 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test Card | Device ID: 439 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 | Device ID: 440 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Zeesan Biotech Co., Ltd | Commercial: SARS-CoV-2 Test Kit | Device ID: 441 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Yuno Diagnostics Co., Ltd | Commercial: Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits | Device ID: 444 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co., Ltd | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit | Device ID: 452 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhengzhou Humanwell Biocell Biotechnology Co., Ltd | Commercial: BIOCELL COVID-19 IgG ELISA test | Device ID: 453 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhengzhou Humanwell Biocell Biotechnology Co., Ltd | Commercial: BIOCELL COVID-19 IgM ELISA test | Device ID: 454 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Changsha Sinocare, Inc | Commercial: SARS-CoV-2 Antibody Test Strip | Device ID: 460 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Wondfo SARS-CoV-2 Antibody Test (lateral flow method) | Device ID: 461 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 463 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biozek Medical | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 464 | 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 Cassette | Device ID: 465 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | Device ID: 466 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AITbiotech | Commercial: abTES COVID-19 qPCR I Kit | Device ID: 468 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: Simplexa COVID-19 Direct RT-PCR Kit | Device ID: 471 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EurobioPlex SARS-CoV-2 Multiplex | Device ID: 473 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method | Device ID: 474 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Gold - OZO SARS-CoV-2 IgG Method | Device ID: 475 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Silver - OZO SARS-CoV-2 IgM Method | Device ID: 476 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co., Ltd | Commercial: LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Device ID: 477 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hecin Scientific, Inc | Commercial: COVID-19 IgM Antibody Rapid Test Kit | Device ID: 478 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: iNtRON Biotechnology Inc | Commercial: LiliF COVID-19 Real-time RT-PCR Kit | Device ID: 480 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: ARIES SARS-CoV-2 Assay | Device ID: 481 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-CoV-2 Rapid TesIgM/IgG | Device ID: 485 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sacace BIOTECNOLOGIES | Commercial: SARS-CoV-2 Real-TM | Device ID: 487 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: U2USystems (India) Pvt. Ltd | Commercial: 2019-ncoV IgG/IgM Test | Device ID: 489 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio, Inc | Commercial: careGENE COVID-19 RT-PCR kit | Device ID: 493 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio, Inc | Commercial: careGENE N-CoV RT-PCR kit | Device ID: 494 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott ID NOW COVID-19 | Device ID: 496 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | Device ID: 497 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Medomics Medical Technologies | Commercial: SARS-CoV-2 rapid combined IgM/IgG antibody test kit | Device ID: 500 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-COV-2 Rapid Test | Device ID: 501 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sona Nanotech | Commercial: Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein | Device ID: 502 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: MOLgen SARSCoV2 Real Time RT PCR | Device ID: 508 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amplicon Ltd | Commercial: AmpliTest SARS-CoV-2 (Real Time PCR) | Device ID: 509 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit | Device ID: 510 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Confirmation RT-Qpcr | Device ID: 511 | Method: RT-PCR | Target: Nucleic acid | 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