CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: SARA-CoV-2 Antigen Rapid Test Kit | Device ID: 1986 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2203 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON SARS-CoV-2 S1/S2 IgG | Device ID: 911 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON® SARS-CoV-2 Ag | Device ID: 1960 | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | Go to details |
CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON® SARS-CoV-2 TrimericS IgG (Ref.311510) | Device ID: 1900 | Method: Immunoassay | Target: IgG | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: Simplexa COVID-19 Direct RT-PCR Kit | Device ID: 471 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: DIAsource ImmunoAssays | Commercial: COVID-19 Antigen Rapid Test | Device ID: 1792 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Diatech Pharmacogenetics | Commercial: Easy SARS-CoV-2 | Device ID: 843 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Diatherix Eurofins Laboratory | Commercial: SARS-CoV-2 PCR Test | Device ID: 717 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Diatheva SRL | Commercial: COVID-19 PCR DIATHEVA Detection kit | Device ID: 148 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgG | Device ID: 670 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit | Device ID: 1416 | Method: CLIA | Target: Antibody, IgM | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Macurra SARS-CoV-2 PCR Kit | Device ID: 1417 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: CHORUS SARS-CoV-2 "NEUTRALIZING" Ab | Device ID: 2712 | Method: ELISA | Target: | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: CHORUS SARS-CoV-2 ANTIGEN | Device ID: 2708 | Method: ELISA | Target: Antigen | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: CHORUS SARS-CoV-2 IgA | Device ID: 2709 | Method: ELISA | Target: IgA | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: CHORUS SARS-CoV-2 IgG | Device ID: 2710 | Method: ELISA | Target: IgG | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: CHORUS SARS-CoV-2 IgM | Device ID: 2711 | Method: ELISA | Target: IgM | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: CHORUS SARS-CoV-2 SCREEN SERUM | Device ID: 2731 | Method: ELISA | Target: | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgA | Device ID: 980 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgG | Device ID: 981 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgM | Device ID: 982 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: iRAPID SARS-CoV-2 QUANT “NEUTRALIZING” Ab | Device ID: 2732 | Method: Immunochromatography | Target: IgG | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Dixion Safetest SARS-CoV-2 Antigen Speichel Schnelltest | Device ID: 2489 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Dixion Sars-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2644 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
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: No | Manufacturer: DNA Software Inc. | Commercial: Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B | Device ID: 472 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: DNA Xperts Pvt Ltd. | Commercial: FAST RT-PCR KIT, Real time PCR kit for COVID19 detection | Device ID: 542 | Method: RT-PCR | Target: Nucleic acid | 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: No | Manufacturer: Dynamic Code AB | Commercial: Covid-19 PCR | Device ID: 2550 | Method: RT-PCR | Target: | Format: Lab-based | 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 |
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