| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2 Double Antigen Multi-species | 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 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innovita Biological Technology | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Innovita Biological Technology | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Innovita Biological Technology | Commercial: SARS-CoV-2 antibody assay | 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 | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Instituto de Medicina Genómica | Commercial: Imegen SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Instituto de Medicina Genómica | Commercial: Imegen SARS-CoV-2 plus | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: Rapid SARS-CoV-2 Antibody (IgM/IgG) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: Rapid SARS-CoV-2 Antibody Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: SARS-CoV-2 Antibody | 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) | 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 | Method: Immunoassay | Target: Antigen | 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 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Integrated Nano-Technologies | Commercial: Palladium | Method: Other | Target: Other | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Integrity Laboratories | Commercial: SARS-CoV-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: InTelos, Inc. | Commercial: MAUVE COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Intermedical SRL | Commercial: 2019-NCOV IGG/IGM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: iNtRON Biotechnology Inc | Commercial: LiliF COVID-19 Real-time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Invenio Medical | Commercial: COVID-19 IgG/IgM Ab Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Inzek international trading bv | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-502 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: IONTEK İLAÇ TANI VE BİYOTEKNOLOJİ ÜRÜNLERİ AR.GE.SAN. VE TİC. A.Ş. | Commercial: Fluorion nCoV-19 QLP 2.1 Real-Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Ipsum Diagnostics | Commercial: COV-19 IDx assay | 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) | 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) | 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 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit | Method: Immunoassay | Target: Antibody | 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 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: PerfectQ COVID-19 Coronavirus Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu CoWin Biotech | Commercial: SARS-CoV-2 Detection Kit (qPCR Probe Assays) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Dabo Pharmaceutical Co., Ltd | Commercial: Rapid test for IgM/IgG Antibody to SARS-CoV-2 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Diagnostics Biotechnology Co.,Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | Commercial: COVID-19 Salivary Antigen Rapid Test Kit（Colloidal Gold） | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Medomics Medical Technologies | Commercial: SARS-CoV-2 rapid combined IgM/IgG antibody test kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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 | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: 2019-Novel Coronavirus (ORF1ab, E &N genes) Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: 2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: 2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Qitian Gene Biotechnology Co., Ltd | Commercial: Fluorescent RAA Detection for 2019-nCoV | 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) | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JinHuan Medical Instrument Co., Ltd | Commercial: (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JN Medsys | Commercial: ProTect Covid-19 RT-qPCR kit | 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