| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Yes | Manufacturer: Innovative Diagnostics | Commercial: iD Rapid® COVID-19 Antigen | Device ID: 1728 | Method: Immunoassay | Target: Antigen | 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: Yes | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2-N IgG Indirect | Device ID: 1726 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Device ID: 227 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) | Device ID: 1994 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) (Anterior Nasal Swab) | Device ID: 2910 | Method: Immunoassay | 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: 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: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgA | Device ID: 2747 | Method: ELISA | Target: IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgG | Device ID: 2745 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgM | Device ID: 2748 | Method: ELISA | Target: IgM | Format: Automated, Manual | 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: Yes | Manufacturer: InTec Products Inc. | Commercial: AQ+ COVID-19 Ag Rapid Test | Device ID: 3084 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: AQ+ COVID-19 Ag Rapid Test | Device ID: 3098 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antibody (IgM/IgG) | Device ID: 229 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antibody Test | Device ID: 228 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test | Device ID: 2484 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen) | Device ID: 2419 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal/nasal specimen) | Device ID: 1783 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: SARS-CoV-2 Antibody | Device ID: 1018 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: SARS-CoV-2 Antibody (IgM/IgG) | Device ID: 1017 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Yes | Manufacturer: InTelos Inc. | Commercial: MAUVE COVID-19 Ag Test | Device ID: 1882 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: Yes | Manufacturer: intron biotechnology | Commercial: LiliF COVID-19 Real-time RT-PCR Kit | Device ID: 480 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: intron biotechnology | Commercial: LiliF GBN Covid-19 Ag Rapid kit | Device ID: 2069 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: Yes | Manufacturer: Inzek International trading | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-502 | Device ID: 1988 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Inzek International trading | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-802 | Device ID: 1987 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Iontek | Commercial: Fluorion nCoV-19 QLP 2.1 Real-Time PCR Kit | Device ID: 1721 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Other, Semi-automated | 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: Yes | Manufacturer: ISO13485 | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold ) | Device ID: 2138 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: Yes | Manufacturer: iXensor | Commercial: PixoTest® POCT COVID-19 Antigen Test | Device ID: 2217 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Baozhilin Medical Co Ltd | Commercial: SARS-COV-2 Antigen Rapid Test Kit | Device ID: 5754 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Baozhilin Medical Technology Co. Ltd. | Commercial: SARS-COV-2 Antigen Rapid Test Kit | Device ID: 2821 | Method: Immunochromatography | Target: Antigen | Format: Fully automated (robot), Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Baozhilin Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 IgG/IgM rapid test kits（Golloidal Gold) | Device ID: 2833 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Baozhilin Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibodies Test kits (Colloidal Gold) | Device ID: 2832 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Besthree Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Rapid Ag Test (Colloidal Gold) | Device ID: 3012 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 2107 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit | Device ID: 236 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 1264 | Method: Immunoassay | Target: Antigen | 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