CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Dixion SARS-CoV-2 Neutralizing antibody test kit | Device ID: 2492 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DN Laboratory Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Testing Cassette(GICA)/COVID-19 Antigen Testing Cassette(GICA) | Device ID: 2955 | Method: Immunochromatography | Target: Antibody, Antigen, IgA, IgG, IgM | Format: Lab-based, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: COVID-19 Antigen Detection Kit | Device ID: 2242 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2756 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testing | Device ID: 2814 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DNA Research Center Ltd. | Commercial: CBDNA RT-LAMP RAPID TEST | Device ID: 2607 | Method: LAMP | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: DNA-Technology R&D LLC | Commercial: SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit | Device ID: 1109 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Dotz Nano Ltd. | Commercial: Dotz SARS-CoV-2 Rapid Diagnostic Kit | Device ID: 2927 | Method: LAMP | Target: Nucleic acid | Format: Automated, Fully automated (robot), Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Dräger Safety AG & Co. KGaA | Commercial: Dräger Antigen Test SARS-CoV-2 | Device ID: 2273 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dräger Safety AG & Co. KGaA | Commercial: Dräger COVID-19 Home Test | Device ID: 2647 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DS Bio and Nano Technology Product Tracking Verification Corp. | Commercial: DS AntijenX | Device ID: 2551 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod SARS-CoV-2 qAg Test Kit | Device ID: 1717 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod® SARS-CoV-2 IgG Test Kit | Device ID: 1719 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod®616 COVID-19 Ag Test Kit | Device ID: 1718 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod®616 IgG Test Kit | Device ID: 1720 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: 2019 nCOV IgG/IgM Rapid Test | Device ID: 152 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: 2019-nCOV IgG Antibody kit (ELISA) | Device ID: 844 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: 2019-nCOV IgM Antibody kit (ELISA) | Device ID: 845 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: Novel Coronavirus(2019-nCov)RT-PCR Kit | Device ID: 151 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology(Tianjin) Co. Ltd. | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Device ID: 3995 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology(Tianjin) Co. Ltd. | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Device ID: 2533 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: CORONA-Ag | Device ID: 1662 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: CovidAg | Device ID: 1663 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device. | Device ID: 991 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovidAg | Device ID: 1651 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: FluCov2 | Device ID: 1664 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: SieloCovidAg | Device ID: 2007 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Device ID: 156 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: ActivXpress+ COVID-19 Antigen Complete Testing Kit | Device ID: 1243 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: COVID-19 Real-time PCR Testing Kit | Device ID: 155 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined | Device ID: 662 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Eiken Chemical Co. Ltd. | Commercial: Loopamp SARS-CoV-2 Detection kit | Device ID: 1638 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 BASIC A RT | Device ID: 548 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 BASIC A500 RT | Device ID: 846 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 CONFIRM RT | Device ID: 847 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: GeneFinder COVID-19 Plus RealAmp Kit | Device ID: 889 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: SARS-CoV-2 ELITe MGB® Kit | Device ID: 1861 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based | Go to details |
CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: SARS-CoV-2 PLUS ELITe MGB® Kit | Device ID: 1862 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: EMBIO Diagnostics Ltd. | Commercial: CovBELD | Device ID: 1313 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Enbiotech s.r.l | Commercial: SARS-CoV-2 POC | Device ID: 3006 | Method: LAMP | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Ender diagnostics ag | Commercial: ender LAB | Device ID: 1184 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Ender diagnostics ag | Commercial: ender MASS | Device ID: 1183 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Enimmune Corporation | Commercial: Speedy COVID-19 Ag Rapid Test | Device ID: 3013 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: EON Biotechnology Limited | Commercial: EONBT COVID-19 Antigen | Device ID: 2032 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Epigentek Group Inc. | Commercial: SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit | Device ID: 1044 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Epitope Diagnostics Inc. | Commercial: EDI Novel Coronavirus COVID-19 IgG ELISA Kit | Device ID: 157 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Epitope Diagnostics Inc. | Commercial: EDI Novel Coronavirus COVID-19 IgM ELISA Kit | Device ID: 158 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Erba Mannheim | Commercial: ErbaLisa COVID-19 IgG ELISA | Device ID: 533 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Eryigit Biomedical Devices | Commercial: Covid-19 qRT PCR Detection Kit | Device ID: 550 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eryigit Biomedical Devices | Commercial: Sentebiolab Senteligo SARS-CoV-2 (COVID-19) Multiplex qPCR Detection Kit | Device ID: 1300 | 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