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

    LeukoStrat CDx FLT3 Mutation Assay

    Code: 081002273K41204314J
    View on EUDAMED
    Devices
    2
    Certificates
    0
    Notified Bodies
    0
    Auth. Representatives
    1

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    Basic Information

    UDI-DI Code
    081002273K41204314J
    Issuing Agency
    GS1
    Types
    Companion diagnostics Kit Human tissues Professional testing Reagent
    Regulation
    Eu Ivdr
    Classification
    Eu Ivd Class C
    Manufacturer
    Invivoscribe, Inc.
    Last Updated
    October 10, 2023

    Certificate Health

    No certificates associated with this Basic UDI-DI.

    Associated Devices

    This Basic UDI-DI is associated with 2 devices.

    Name Status
    LeukoStrat CDx FLT3 Mutation Assay On the market
    LeukoStrat CDx FLT3 Mutation Assay No longer on the market