| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Jiangxi Province JinHuan Medical Instrument Co. Ltd. | Commercial: DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit | Device ID: 2963 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dia Sure Immunodiagnostic LLP | Commercial: DSI COVID-19 Ag RAPID TEST | Device ID: 3144 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology（Tianjin) Co. Ltd. | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Device ID: 3995 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovidAg | Device ID: 1651 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Encode Medical Engineering Co. Ltd. | Commercial: ENCODE SARS-COV-2 Antigen rapid Test Device | Device ID: 1902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Encode Medical Engineering Co. Ltd. | Commercial: ENCODE SARS-COV-2 Antigen rapid Test Device | Device ID: 2587 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: ENMED SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4083 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Manufactured by Eon Biotechnology Limited | Commercial: EONBT COVID-19 ANTIGEN-SALIVA | Device ID: 2161 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fujirebio | Commercial: ESPLINE SARS-CoV-2 | Device ID: 2147 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EXON BÄ°YOTEKNOLOJÄ° | Commercial: EXON SARS CoV-2 Rapid Antigen Test (Colloidal Gold) | Device ID: 2953 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: FAGO MEDÄ°KAL SANAYÄ° TÄ°CARET Ltd. ÅžTÄ°. | Commercial: FAMEX Coronavirus (2019-nCoV) Antigentest | Device ID: 2053 | Method: Immunochromatography | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Link Technology Co. Ltd. | Commercial: FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit | Device ID: 2937 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: ACON Laboratories Inc. | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Device ID: 1670 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex Anti-SARS-CoV-2 S Antibody Rapid Test | Device ID: 2951 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test | Device ID: 4054 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test | Device ID: 1457 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: Flowflex SARS-CoV-2 Antigen rapid test | Device ID: 1468 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Nasopharyngeal/Saliva) | Device ID: 4057 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Device ID: 1865 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva) | Device ID: 4050 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim | Device ID: 4053 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing) | Device ID: 4052 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing) | Device ID: 4051 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co. Ltd. | Commercial: Flu A/B & COVID-19 Ag Combo Test | Device ID: 5787 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: Flu A/B + COVID-19 Antigen Combo Test Cassette Kit | Device ID: 2340 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: FluCov2 | Device ID: 1664 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: fluorecare SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2181 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: fluorecare SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay) | Device ID: 2182 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: fluorecare SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay) | Device ID: 2168 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: FORA SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) | Device ID: 2700 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ag CARD | Device ID: 2724 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: GA Generic Assays GmbH | Commercial: GA CoV-2 Antigen Rapid Test | Device ID: 1855 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: General Biologicals Corporation | Commercial: GB COVID-19 Ag POCT | Device ID: 4081 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenBody Inc. | Commercial: GenBody COVID-19 Ag | Device ID: 1244 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GC Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag | Device ID: 1144 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GC Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag (643K) | Device ID: 3190 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genius Pharmaceutical AG | Commercial: GENnasal SARS-CoV-2 Antigen Rapid Test | Device ID: 3149 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: GENnasal SARS-CoV.2 Antigen Rapid Test | Device ID: 3146 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Antigen Rapid Kit | Device ID: 1253 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate COVID-19 Neutralizing antibody | Device ID: 2861 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lvshiyuan Biotechnology Co. Ltd. | Commercial: Green Spring SARS-CoV-2 Antigen-Rapid test-Set | Device ID: 2109 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Healvet Medtech GZ Ltd. | Commercial: Healfo SARS-CoV-2 Ag Saliva Rapid Test | Device ID: 2974 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: Hightop COVID-19 IgM/IgG Ab Rapid Test Kit | Device ID: 325 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 Ag Home Test | Device ID: 2276 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 Ag Test | Device ID: 1263 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 IgG/IgM Test | Device ID: 219 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 Ag | Device ID: 1990 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zhengzhou Fortune Bioscience Co. Ltd. | Commercial: IgG/IgM Antibody Rapid Test Kits (Colloidal Gold Immunochromatography method) | Device ID: 699 | Method: Immunochromatography | 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