| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody Neutralizing Rapid Test Cassette | Device ID: 2615 | Method: Immunochromatography | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: simin.chen@lifotronic.com | Commercial: Nucleic Acid Extraction Reagent | Device ID: 2614 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2613 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensiva Health LLC | Commercial: Sensiva Health React Rapid Antigen Test (Lateral Flow Method) | Device ID: 2611 | Method: Immunoassay | Target: Antigen, IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensiva Health LLC | Commercial: Sensiva Health Spectrum Rapid COVID-19 Antigen Test | Device ID: 2610 | Method: Immunoassay | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 Test Kit (Colloidal Gold Method)(Nasal Swab) | Device ID: 2609 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. Ltd. | Commercial: COVID 19 Antigen Test Kit (Colloidal Gold Method) | Device ID: 2608 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: DNA Research Center Ltd. | Commercial: CBDNA RT-LAMP RAPID TEST | Device ID: 2607 | Method: LAMP | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) （Saliva） | Device ID: 2606 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) | Device ID: 2605 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva | Device ID: 2604 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 2603 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Baicare(Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2602 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | 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: Ustar Biotechnoligies | Commercial: Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal AmplificationReal Time Fluorescence Assay) | Device ID: 2600 | Method: Other | Target: Nucleic acid | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Z Biotech Inc. | Commercial: AnyLab COVID-19 Ag Test Kit | Device ID: 2599 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit | Device ID: 2598 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 2597 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2596 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Ag Combo FIA | Device ID: 2595 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test | Device ID: 2594 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay) | Device ID: 2593 | Method: Immunoassay | Target: IgG, IgM | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay) | Device ID: 2592 | Method: Immunoassay | Target: Antibody | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay) | Device ID: 2591 | Method: Immunoassay | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) | Device ID: 2590 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Total Antibody /Neutralizing Antibody (Colloidal Gold) | Device ID: 2589 | Method: Immunoassay | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Device ID: 2588 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, 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: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Cassette | Device ID: 2586 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) | Device ID: 2585 | 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: INFO Covid-19 Ag Test | Device ID: 2584 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Polonord Adeste Srl | Commercial: POLOFLUOR 2 | Device ID: 2583 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: MERISCREEN COVID-19 Antigen Detection Test | Device ID: 2582 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette | Device ID: 2581 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Saliva) | Device ID: 2580 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell SARS-CoV-2 Ag Cassette | Device ID: 2579 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Nasal Swab) | Device ID: 2578 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Bionaire Biotech Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test (Colloidal Gold) | Device ID: 2577 | Method: Immunochromatography | Target: Antigen | Format: | 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: Devidia GmbH | Commercial: Dediatest Frontnasal 2019-nCoV Antigen | Device ID: 2575 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest 2019-nCoV Antigen Rapid Test (Nasopharyngeal) | Device ID: 2574 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart(TM) COVID-19 IgM/IgG | Device ID: 2573 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart(TM) COVID-19 Antigen | Device ID: 2572 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV-2 IgM/IgG (N) | Device ID: 2571 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) | Device ID: 2570 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, 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: Dianext | Commercial: SARS-CoV-2 antigen Immunofluorescence assay | Device ID: 2568 | Method: Immunochromatography | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Centrum Badań DNA ul. Ściegiennego 20 60-128 Poznań | Commercial: CBDNA RT-LAMP RAPID TEST | Device ID: 2567 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Innovation Scientific Pty Ltd. | Commercial: InnoScreenTM COVID-19 Antigen Rapid Test Device | Device ID: 2566 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Innovation Scientific Pty Ltd. | Commercial: InnoScreenTM COVID-19 IgG/IgM Rapid Test Device | Device ID: 2565 | Method: Immunochromatography | Target: Antibody, IgG, IgM | 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