| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Nanjing BioPoint Diagnostics | Commercial: BioPoint SARS-CoV-2 dIgA/total antibody rapid test | Device ID: 290 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 BSS | Device ID: 779 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Boditech Quick™ COVID-19 Neutralizing Ab | Device ID: 2785 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: Camtech COVID-19 Rapid Test Kit | Device ID: 111 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Access Bio Inc. | Commercial: CareStart COVID-19 IgM/IgG | Device ID: 506 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Wells Bio Inc. | Commercial: careUS COVID-19 IgM/IgG | Device ID: 632 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CAT | Device ID: 1199 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cellex Inc. | Commercial: Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test | Device ID: 116 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST | Device ID: 2696 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASOPHARYNGEAL ANTIGEN TEST | Device ID: 2746 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co. Ltd. | Commercial: ChekR™ COVID-19 IgM/IgG Rapid test | Device ID: 1613 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) | Device ID: 2312 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold) | Device ID: 2313 | 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 (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 (Nasal Swab) | Device ID: 3072 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold) | Device ID: 2314 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2307 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2308 | 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 (Nasal Swab) - self-test | Device ID: 3080 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2516 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM Antibody Diagnostic Kit （Colloidal Gold) | Device ID: 357 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2311 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NB POSTECH | Commercial: Chexel COVID-19 IgM/IgG | Device ID: 1303 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | Commercial: CHIL COVID-19 Antigen Rapid Test | Device ID: 3864 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | Commercial: CHIL COVID-19 Antigen Rapid Test (Nasal / Nasopharyngeal / Oropharyngeal Swab-Casette) | Device ID: 1691 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CHIL Medical Supplies Ltd. | Commercial: CHiL COVID-19 IgG/IgM Rapid Test cassette | Device ID: 1098 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Chlamydia Antigen Rapid Test Cassette | Device ID: 3138 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: servoprax GmbH | Commercial: Cleartest Corona, Covid-19 | Device ID: 354 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Luminostics Inc. | Commercial: CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) | Device ID: 267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: Clungene COVID-19 IgM/IgG Rapid Test Cassette | Device ID: 675 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CMANU | Commercial: CNAME | Device ID: 3922 | Method: Immunoassay | Target: Antibody | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM | Device ID: 34 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Fenghua Bioengineering Co. Ltd. | Commercial: Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody | Device ID: 199 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Applied Biomedical LLC | Commercial: Confidence COVID-19 Rapid Test | Device ID: 767 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abioteq GmbH | Commercial: Cora Gentest-19 | Device ID: 2374 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fameditec GmbH | Commercial: CORA-CHECK-19-comfort | Device ID: 1781 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co. Ltd. | Commercial: Coretests COVID-19 Neutralizing Ab Test | Device ID: 1923 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co. Ltd. | Commercial: Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold) | Device ID: 1930 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: Corona Virus Disease-19(COVID-19)IgG/IgM Rapid | Device ID: 1337 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: CORONA-Ag | Device ID: 1662 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: CoronaCide | Commercial: CoronaCide | Device ID: 341 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) | Device ID: 2285 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RayBiotech | Commercial: Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) | Device ID: 337 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 2031 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 1343 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1440 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: Coronavirus COVID-19 lgM/IgG Test Kit (colloidal) | Device ID: 1428 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) | Device ID: 519 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) | Device ID: 521 | Method: Immunoassay | Target: Antibody | 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