BEUDAMED
    Basic UDI-DI Eu Ivdr Eu Ivd Class C 🇺🇸 United States

    Oncotype DX Breast Recurrence Score® Test

    Code: 0852867008100406DG
    View on EUDAMED
    Devices
    3
    Certificates
    0
    Notified Bodies
    0
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    0852867008100406DG
    Issuing Agency
    GS1
    Types
    Professional testing Reagent Software
    Regulation
    Eu Ivdr
    Classification
    Eu Ivd Class C
    Manufacturer
    Genomic Health Inc.
    Last Updated
    February 13, 2024

    Certificate Health

    No certificates associated with this Basic UDI-DI.

    Associated Devices

    This Basic UDI-DI is associated with 3 devices.

    Name Status
    Oncotype DX Breast Recurrence Score® Kit On the market
    Oncotype DX Breast Recurrence Score® Kit On the market
    Oncotype DX Breast Recurrence Score® Computational Software On the market