| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co. Ltd. | Commercial: COVID-19 & Influenza A+B Antigen Combo Test Kit (Colloidal Gold) | Device ID: 1354 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Saliva Test Kit (Colloidal Gold) | Device ID: 1617 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co. Ltd. | Commercial: Influenza A+B Antigen Test Kit (Colloidal Gold) | Device ID: 1301 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Egens Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 1573 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Natejah | Commercial: (COVID-19) IgG/IgM Rapid Test | Device ID: 1019 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nationwide Children's Hospital | Commercial: SARS-CoV-2 Assay | Device ID: 739 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 ANTIGENIC TEST FOR SARS-COV-2 | Device ID: 2348 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-2 | Device ID: 2349 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Naturitious LLC | Commercial: Viralert COVID-19 IgG/IgM Antibody Rapid Test Kit | Device ID: 484 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Navid | Commercial: COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) | Device ID: 326 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NB POSTECH | Commercial: Chexel COVID-19 IgM/IgG | Device ID: 1303 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NDFOS Co. Ltd. | Commercial: ND COVID-19 Ag Test | Device ID: 2678 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NEMHESIS LAB. SÄ°S. MED. PLAS. ENJEK. Ä°ML. Ä°TH. Ä°HR. SAN. TÄ°C. Ltd. ÅžTÄ°. | Commercial: NEMI COVID-19 RAPID ANTIGEN TEST KIT | Device ID: 3155 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. Ltd. | Commercial: 2019-nCoV(COVID-19) IgG&IgM Rapid Test Kit | Device ID: 1022 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. Ltd. | Commercial: COVID 19 Antigen Test Kit (Colloidal Gold Method) | Device ID: 2608 | Method: Immunoassay | Target: Antigen | Format: | 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: 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 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 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: SARS-COV-2 Ag NeoMedica | Device ID: 2236 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: SARS-COV-2 Ag NeoMedica (R2703Ag) | Device ID: 2234 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NESAPOR EUROPA SL | Commercial: MARESKIT | Device ID: 2241 | Method: Immunoassay | 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: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antibody Detection Kit | Device ID: 2306 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit | Device ID: 1501 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use) | Device ID: 2303 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Detection Kit | Device ID: 2305 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19/Influenza A/Influenza B Detection Kit | Device ID: 2330 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Newbury Pharmaceuticals S.A | Commercial: COVID-19 Coronavirus Rapid Test Kit | Device ID: 1029 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 and Influenza A+B Rapid Antigen Combo Test | Device ID: 2845 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 Antigen Cassetle Rapid Test (Pharyngeal swab) | Device ID: 2844 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 Antigen Mircrofluidic Chip | Device ID: 2820 | Method: Immunoassay | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 Antigen Rapid Test Cassetle | Device ID: 2847 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: Influenza Antigen A/B Rapid Test | Device ID: 2846 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Next Pharma Inc. | Commercial: DiaCarta's QuantiVirusTMSARS-CoV-2 Test | Device ID: 295 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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: Ninonasal | Device ID: 1880 | Method: Immunochromatography | Target: Antigen | Format: 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: No | Manufacturer: Ningbo Beautiful Life Medical Biotechnology Development Co. Ltd. | Commercial: Saliva SARS-Cov-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay) | Device ID: 2250 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ningbo Health Gene Technologies Co. Ltd. | Commercial: SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) | Device ID: 296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ningbo Home Test Bio-echnology Co. Ltd. | Commercial: SARS-oV- Antigen Rapid Test kit (Saliva Test) | Device ID: 2021 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NINGBO LVTANG BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Device ID: 4049 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: pGOLD COVID-19 IgG/IgM/IgA Microarray Test | Device ID: 793 | Method: Other | Target: Antibody, IgA, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Device ID: 297 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Norgen Biotek Corp. | Commercial: 2019-nCoV TaqMan RT-PCR Kit (Catalog# TM67100) | Device ID: 298 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: 2019-nCoV TaqMan RT-PCR Kit Dx (DxTM67100) | Device ID: 1158 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: COVID19 TaqMan RT-PCR Kit Dx (E-RdRP genes) (DxTM67200) | Device ID: 1160 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Saliva / Swab RNA Purification Kit Dx (Cat#Dx69100) | Device ID: 1176 | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: Saliva RNA Collection and Preservation Devices Dx (Cat#53800) | Device ID: 1174 | Method: Other | Target: Nucleic acid | Format: Other | 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