BEUDAMED
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    16 BIT INC

    FDA registration
    16 BIT INC·1 product·🇨🇦 Canada

    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