| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | Device ID: 2019 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou TianLong Biotechnology Co., Ltd., | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method) | Device ID: 2488 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Biotechnology Co., Ltd | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit | Device ID: 1415 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Device ID: 1785 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co., Ltd | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit | Device ID: 452 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc | Commercial: Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) | Device ID: 786 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | 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 (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Device ID: 2506 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) | Device ID: 1795 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing WSWY Technology Co.,.Ltd | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography) | Device ID: 1362 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Highcreation Technology Co., Ltd | Commercial: Novel Corona- virus IgM/IgG Combo Rapid Test | Device ID: 1345 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: 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: Chongqing Novegent Biotech Company Limited | Commercial: Novegent COVID-19 Antigen Rapid Test Kit | Device ID: 1189 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing Novegent Biotech Company Limited | Commercial: Novegent COVID-19 Antibodies Rapid Test Kit | Device ID: 1185 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: NovaLisa SARS-CoV-2 IgG assay | Device ID: 725 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa SARS-CoV-2 (COVID-19) | Device ID: 819 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgM | Device ID: 589 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgG | Device ID: 588 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgA | Device ID: 587 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Novatech | Commercial: NOVACHECK Diagnostic kit (collodial gold) for IgG/IgM Antibody to SARS-CoV-2 | Device ID: 1393 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Link Technology Co., Ltd. | Commercial: NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 2010 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: Ninonasal-Autotest | Device ID: 2281 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: Ninonasal | Device ID: 1880 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: NG-Test SARS-CoV-2 Ag | Device ID: 1646 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: NG-Test IgG-IgM COVID-19 | Device ID: 865 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Formaster Biosci Co., Ltd. | Commercial: New Coronavirus (COVID-19) Antigen Rapid Test (saliva) | Device ID: 2480 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Formaster Biosci Co., Ltd. | Commercial: New Coronavirus (COVID-19) Antigen Rapid Test | Device ID: 2089 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NeuMoDx Molecular | Commercial: NeuMoDx SARS-CoV-2 Assay | Device ID: 740 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: GeneMatrix Inc | Commercial: NeoPlex COVID-19 Detection Kit | Device ID: 657 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD. | Commercial: nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum) | Device ID: 2141 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics, Inc | Commercial: nCOV IgG/IgM Rapid Test | Device ID: 1078 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd | Commercial: nCoV IgG/IgM combo test | Device ID: 1023 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: nConV-19 Nucleic Acid qPCR Kit | Device ID: 35 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: NanoRepro AG | Commercial: NanoRepro SARS-CoV-2 Antigen Rapid Test | Device ID: 2200 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nano-Ditech Corporation | Commercial: Nano-Check COVID-9 IgG/IgM Antibody Test | Device ID: 938 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 S1/S2/RBD Neutralizing antibodies | Device ID: 2377 | Method: ELISA | Target: Antibody, IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 IgM | Device ID: 1133 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 IgG | Device ID: 1087 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 IgA | Device ID: 1134 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 IgG/IgM Test (243003N-25 and 243001N-10) | Device ID: 289 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 Ag Test | Device ID: 1162 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID -19 Ag +Influenza A/B Test | Device ID: 2104 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: MyBox Flurescence Immunoassay Analyzer | Device ID: 2423 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit | Device ID: 582 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: MutaPLEX® CoV-2 MUT real time RT-PCR Kit | Device ID: 1850 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: MutaPLEX® Coronavirus Real-Time-RT-PCR-Kit | Device ID: 2014 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co., Ltd | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV (manual & automated lab-based) | Device ID: 57 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing NaGene Diagnosis Reagent Co., Ltd | Commercial: Multiple Real-Time PCR kit for Detection of 2019-nCoV | Device ID: 75 | 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