| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Jiangxi YeLi Medical | Commercial: Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) | Device ID: 658 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JIAXING WISETEST BIO-TECH Co. Ltd. | Commercial: ABtex AG | Device ID: 2528 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JINAN BABIO BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) | Device ID: 4046 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JINAN BABIO BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) | Device ID: 2151 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JinHuan Medical Instrument Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Device ID: 575 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JN Medsys | Commercial: ProTect Covid-19 RT-qPCR kit | Device ID: 932 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: /COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal - self testing device | Device ID: 2875 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test (Latex) | Device ID: 1205 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: COVID-19 Rapid Antigen Test (Colloidal Gold) | Device ID: 1333 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold) | Device ID: 1204 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) | Device ID: 1776 | Method: Immunoassay | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: SARS-COV-2/Influenza A&B Rapid Antigen Test | Device ID: 1777 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold) | Device ID: 933 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1764 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold) | Device ID: 1766 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit-PRO (Colloidal Gold) | Device ID: 2813 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JRC | Commercial: Test.11.12.2024 | Device ID: 25665 | Method: CRISPR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: K.K. Mirai Genomics | Commercial: LifePad Analyzer | Device ID: 2899 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: K.K. Mirai Genomics | Commercial: Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method | Device ID: 2898 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Kaya17 Inc. | Commercial: nCoVega Saliva-Based Rapid Antigen COVID19 Test | Device ID: 2779 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 Antigen Detection Rapid Test | Device ID: 244 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 IgG and IgM ELISA (manual) | Device ID: 243 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 IgG/IgM Rapid Detection Test Kit | Device ID: 242 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: KH Medical Co. Ltd. | Commercial: RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit | Device ID: 245 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KitL&H Biotech Limited | Commercial: COVID-19 Antigen Rapid Test | Device ID: 1596 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Koch Biotechnology (Beijing) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 2038 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: 2019 Novel Coronavirus Real-time PCR Kit | Device ID: 730 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: PowerChek 2019-nCoV Real-time PCR Kit | Device ID: 246 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat San. Ve Tic Ltd. Sti. | Commercial: Laboquick COVID 19 Ag Rapid Test Kit | Device ID: 2786 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test | Device ID: 248 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test | Device ID: 247 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual) | Device ID: 249 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual) | Device ID: 251 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual) | Device ID: 253 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines) | Device ID: 250 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Krosgen Biotech | Commercial: KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit | Device ID: 576 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Kurabo Industries Ltd. | Commercial: SARS-CoV-2 Antibody IgM/IgG Testing Kit | Device ID: 254 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 Assay | Device ID: 2354 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 Assay plus | Device ID: 2353 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 ExoFast RT-PCR Kit | Device ID: 2351 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 RT-PCR Kit | Device ID: 2352 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit | Device ID: 577 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: SARS-CoV-2 Antigen Influenza A B Rapid Test Kit(Immunochromatography) | Device ID: 3936 | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | Device ID: 1266 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies, Inc. | Commercial: SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit(Immunochromatography) | Device ID: 3928 | Method: | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: LABORATOIRE SALEM | Commercial: Précisio TEST COVID-19 ANTIGENE | Device ID: 3967 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Laboratory Corporation of America | Commercial: LabCorp 2019 Novel Coronavirus test | Device ID: 255 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Labormed Tıbbi Ãœrünler San Ve Tic Ltd. ÅžTÄ° | Commercial: Pekit Covid-19 Rapid (Hızlı) Antigen Test | Device ID: 3010 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Labtest Diagnostica | Commercial: ANTI COVID-19 IGG/IGM RAPID TEST | Device ID: 578 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Laipac Technology Inc. | Commercial: LooK SPOT | Device ID: 1667 | Method: Immunoassay | Target: Antigen | Format: Automated | 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