| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Hunan Yonghe-Sun Biotechnology Co. Ltd. | Commercial: SARS-COV-2 specific antibody test kit (Immunochromatography) | Device ID: 221 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Huwel Lifesciences Pvt. Ltd. | Commercial: Quantiplus CORONA Virus (2019nCoV) detection kit | Device ID: 222 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit | Device ID: 224 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: SCoV-2 Ag Detect Rapid Test | Device ID: 1421 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: InDevR Inc. | Commercial: COVID Serology Kit: Multiplexed Immunoassay | Device ID: 225 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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 |
| CE Marking: No | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2 Double Antigen Multi-species | Device ID: 1727 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR) | Device ID: 226 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: SARS-CoV-2 antibody assay | Device ID: 641 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Institute of Chemical Biology and Fundamental Medicine | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Device ID: 223 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Process Engineering Chinese Academy of Sciences | Commercial: Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based) | Device ID: 479 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Integrated DNA Technologies/Danaher | Commercial: SARS-CoV-2 (2019-nCoV) CDC qPCR Probe Assay | Device ID: 231 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Integrated Nano-Technologies | Commercial: Palladium | Device ID: 656 | Method: Other | Target: Other | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Integrity Laboratories | Commercial: SARS-CoV-2 Assay | Device ID: 727 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Intermedical SRL | Commercial: 2019-NCOV IGG/IGM | Device ID: 1011 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Invenio Medical | Commercial: COVID-19 IgG/IgM Ab Rapid Test | Device ID: 1635 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Ipsum Diagnostics | Commercial: COV-19 IDx assay | Device ID: 728 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1639 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Quantum Dots Immunofluorescence) | Device ID: 1640 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: IVDbio Inc. | Commercial: Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19 | Device ID: 232 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: PerfectQ COVID-19 Coronavirus Real Time PCR Kit | Device ID: 234 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co. Ltd. | Commercial: Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA | Device ID: 237 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co. Ltd. | Commercial: Novel coronavirus 2019-nCoV nucleic acid detection kit (rRT- PCR method) | Device ID: 238 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Qitian Gene Biotechnology Co. Ltd. | Commercial: Fluorescent RAA Detection for 2019-nCoV | Device ID: 239 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Superbio Biomedical Technology (Nanjing) Co. Ltd. | Commercial: Fast SARS-CoV-2 lgM/lgG Antibody Detection Kit (Colloidal Gold) | Device ID: 240 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| 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: 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: 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: 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: 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: No | Manufacturer: Landcent Europe B.V. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Device ID: 256 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 257 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 258 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Lifeassay Diagnostics Pty Ltd. | Commercial: Test-it COVID-19 IgM/IgG Lateral Flow Assay | Device ID: 259 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Lionrun | Commercial: Diagnostic kit for antibody IgM/IgG of Novel Coronavirus COVID-19 | Device ID: 1633 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Lucira Health | Commercial: Lucira COVID-19 All-In-One Test Kit | Device ID: 1374 | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Lumex Instruments | Commercial: Microchip RT-PCR COVID-19 detection system | Device ID: 580 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Luminostics Inc. | Commercial: CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) | Device ID: 267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mammoth Biosciences | Commercial: SARS-CoV-2 DETECTR | Device ID: 273 | Method: CRISPR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgA ELISA | Device ID: 1626 | Method: ELISA | Target: Antibody, IgA | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgM ELISA | Device ID: 1627 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Medical & Biological Laboratories Co. Ltd. | Commercial: FLUOROSEARCH Novel Coronavirus (SARS-CoV-2) Detection Kit | Device ID: 274 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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