| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: No | Manufacturer: Twist Bioscience | Commercial: NGS-based target capture for SARS-CoV-2 detection and screening | Device ID: 412 | Method: Sequencing | Target: Other | Format: Other | 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: No | Manufacturer: NY State Department of Health | Commercial: New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Device ID: 302 | Method: RT-PCR | Target: IgG, IgM, IgA, Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Chinese National Institute for Viral Disease Control and Prevention | Commercial: New coronavirus nucleic acid assay | Device ID: 127 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Testsea Biotechnology Co., Ltd | Commercial: New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent PCR Method) | Device ID: 215 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: No | Manufacturer: Module Innovations Private Ltd | Commercial: nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual) | Device ID: 284 | Method: Immunoassay | Target: Antibody | Format: Automated, 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: No | Manufacturer: NanoResearch | Commercial: NanoMedicina SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 683 | Method: Immunoassay | Target: Antibody | 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: No | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Convective PCR Diagnostic Device/Kit | Device ID: 581 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: Selfdiagnostics Deutschland GmbH | Commercial: Multitest | Device ID: 349 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Tetracore Inc | Commercial: Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual) | Device ID: 401 | Method: Immunoassay | Target: Antibody | Format: Automated, 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 |
| CE Marking: No | Manufacturer: Beijing Beier Bioengineering Co., Ltd | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV | Device ID: 58 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19) | Device ID: 1490 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MSP bodmann GmbH | Commercial: MSP SARS-CoV-2 Antigen Schnelltest | Device ID: 2532 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: MP Rapid 2019-nCoV IgG/IgM | Device ID: 584 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quotient Limited SA | Commercial: MosaiQ COVID-19 Antibody Microarray | Device ID: 600 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Mologic Ltd | Commercial: Mologic COVID-19 Rapid Test | Device ID: 287 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: MOLgen SARSCoV2 Real Time RT PCR | Device ID: 508 | 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