| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 and Influenza A/B Rapid Test Kit | Device ID: 2564 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 Saliva Rapid Test Kit | Device ID: 2563 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2562 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein Antibodies) | Device ID: 2561 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX test | Device ID: 2560 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Solsten Diagnostics Intl. ApS | Commercial: Solsten SARS-CoV-2 Antigen ELISA Kit | Device ID: 2559 | Method: ELISA | Target: Antigen | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold) | Device ID: 2558 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography) | Device ID: 2557 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou LifeReal Biotechnology Co. Ltd. | Commercial: LifeReady 1000 automatic integrated gene detection system | Device ID: 2556 | Method: RT-PCR | Target: | Format: Automated, Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: IEDAU INTERNATIONAL GMBH | Commercial: Covid-19 Antigen Schnelltest (Colloidales Gold) | Device ID: 2555 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: STARK S.A.R.L | Commercial: Stark Portable COVID-19 Antigen Lab | Device ID: 2554 | Method: ELISA | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SPESERA Covid-19 Antijen Hızlı Test Kaseti | Device ID: 2553 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EUROFINS INGENASA | Commercial: INGEZIM COVID RBD-DR | Device ID: 2552 | Method: ELISA | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DS Bio and Nano Technology Product Tracking Verification Corp. | Commercial: DS AntijenX | Device ID: 2551 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Dynamic Code AB | Commercial: Covid-19 PCR | Device ID: 2550 | Method: RT-PCR | Target: | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Rapid Diagnostic Systems Limited | Commercial: NaorCov19 | Device ID: 2548 | Method: LAMP | Target: | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc. | Commercial: SARS-CoV-2 Ultra Rapid Mobile Antigen Test | Device ID: 2547 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: SARS-COV-2 ANTIGEN TEST KIT (COLLOIDAL GOLD) | Device ID: 2546 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: SARS-COV-2 ANTIGEN TEST KIT (COLLOIDAL GOLD) - SALIVA | Device ID: 2545 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2544 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 IgG/IgM Rapid Test Kit | Device ID: 2543 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity IgG/IgM Rapid Test Kit | Device ID: 2542 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein Antibodies) | Device ID: 2541 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2540 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Saliva Antigen Rapid Test Kit | Device ID: 2539 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2538 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV-2 IgM/IgG | Device ID: 2537 | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV2 Influenza A&B Ag combo | Device ID: 2536 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV-2 Ag | Device ID: 2535 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Multibrands Trading(Suzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Qualitative Test | Device ID: 2534 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology（Tianjin) Co. Ltd. | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Device ID: 2533 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MSP bodmann GmbH | Commercial: MSP SARS-CoV-2 Antigen Schnelltest | Device ID: 2532 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test (Quantum Dot Immunofluorescence Chromatography) | Device ID: 2531 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ViennaLab Diagnostics GmbH | Commercial: SARS-CoV-2 RealFast™ Assay | Device ID: 2530 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) for self testing | Device ID: 2529 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: Huachenyang (Shenzhen) Technology Co. Ltd. | Commercial: COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold) | Device ID: 2527 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDICE Arzneimittel Pütter GmbH & Co. KG | Commercial: Medicovid-AG SARS-CoV-2 Antigen Schnelltest-Nase | Device ID: 2526 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: genedrive | Commercial: COV19-ID Kit | Device ID: 2524 | Method: LAMP | Target: | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience Covid-19 Nasopharynx Antigen Test | Device ID: 2523 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience Covid-19 Rapid Antigen Saliva Test | Device ID: 2522 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Vaxxitest 2019-nCoV Neutralizing Antibody Test | Device ID: 2521 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (LFIA) | Device ID: 2520 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH S.L. | Commercial: COVID-19 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2519 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Luminex Molecular Diagnostics Inc. | Commercial: NxTAG® Respiratory Pathogen Panel + SARS-CoV-2 | Device ID: 2518 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd. | Commercial: Orawell COVID-19 Ag Rapid Saliva Test Device (CO-07) | Device ID: 2517 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) IgG / IgM Antibody Testing Kit (Colloidal Gold) | Device ID: 2515 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit (Colloidal Gold) | Device ID: 2514 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hyris Limited | Commercial: bKIT Virus Finder COVID-19 | Device ID: 2513 | Method: RT-PCR | Target: Nucleic acid | Format: Manual, 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