CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: RAPID GOLD PRO CoV-2 AG Test | Device ID: 3133 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: Rapid Gold Pro SARS-CoV-2 AG Test | Device ID: 3143 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: Rapid nCoV & Flu A/B Ag Test Kit (Colloidal Gold) | Device ID: 4098 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) IgG/IgM Combo Test | Device ID: 1903 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) Neutralizing Antibody Test | Device ID: 1904 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test | Device ID: 1236 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Rapid Test Device | Device ID: 2033 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Excalibur Healthcare Services Limited | Commercial: RAPID SARS-COV-2 ANTIGEN SCREENING TEST CARD | Device ID: 2876 | Method: Immunochromatography | Target: Antigen | 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: 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: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal/nasal specimen) | Device ID: 1783 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD | Device ID: 3099 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd. | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1278 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1481 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD (self test) | Device ID: 2902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Rapid SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold) | Device ID: 2569 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid SARS-Cov2 Antigen Test | Device ID: 1791 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST anti- SARS-CoV-2 (RBD) IgG | Device ID: 2334 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST anti- SARS-CoV-2 IgG/IgM | Device ID: 2336 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST SARS-CoV-2 Antigen | Device ID: 2073 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER Covid-19 Ag Test | Device ID: 1751 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1752 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Rapid Ag Test | Device ID: 1443 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Rapid Antigen Test | Device ID: 2180 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Rapid Antigen Test (FIA) | Device ID: 3126 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Rapid Antigen Test Kit (Nasal) | Device ID: 3611 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2 & FLU A/B Antigen Combo Test | Device ID: 4065 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2 & FLU A/B Rapid Antigen Test | Device ID: 4063 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2 + FLU A/B + RSV Combo Test Kit | Device ID: 5804 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2+RSV Combo Test Kit | Device ID: 5810 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: RAPiDgen SARS-CoV-2 Ag Test | Device ID: 2896 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: RAPIDIGEN COVID19 AG IMMUNOASSAY | Device ID: 1823 | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RAPIDNEXT SARS-CoV-2 Rapid Antigen Test | Device ID: 3118 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RAPIDNEXT™ SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4058 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidSens SARS-CoV-2 Rapid Antigen Test | Device ID: 2992 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidSens™ SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4059 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co. Ltd. | Commercial: RapiSafe SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 2978 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Red Cell Biyoteknoloji A.Ş. | Commercial: Red Cell COVID-19 Self Test | Device ID: 3972 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest SARS-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2328 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: Respiratory 13 Pathogen Antigen Test Kit(Colloidal Gold Chromatographic Immunoassay) | Device ID: 25672 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Reszon Diagnostics International Sdn. Bhd. | Commercial: Reszon COVID-19 Rapid Antigen Test | Device ID: 2576 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Reszon Diagnostics International Sdn. Bhd. | Commercial: Reszon COVID-19 Rapid Antigen Test (Nasal Swab) | Device ID: 2938 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®@QUICK SARS-CoV-2 Antigen | Device ID: 1846 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®QUICK SARS-CoV-2 Antigen | Device ID: 2214 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens | Device ID: 5799 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: S2 Covid-19 Rapid Antigen Test Kit | Device ID: 2039 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Bakter Medical s.r.o. | Commercial: Saligen | Device ID: 1782 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Reszon Diagnostics International Sdn. Bhd. | Commercial: Salixium COVID-19 Rapid Antigen Test (Saliva/Nasal Swab Samples) | Device ID: 2601 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS CoV 2 Ag Saliva Rapid Test | Device ID: 2118 | Method: Immunochromatography | 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