BEUDAMED
    108 results · 26ms · Sources: EU EUDAMED, US FDA

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    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018

    ORAgene (Swab-based DNA & Dx Collection Device)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

    Testosterone Saliva ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Testosterone ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Resistin ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Prolactin (PRL) ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Progesterone ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Progesterone Saliva ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Free Estriol ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    Anti-Thyroglobulin (Anti-Tg) ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

    INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI COVID ANTIBODY TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI HIV ANTIBODY SELF-TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HIV ANTIBODY SELF-TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HCV ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HCV ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HCV ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device