BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AlloMap Heart

    Reg #: 3005225997 · FEI: 3005225997 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CareDx, Inc.
    Registration Number
    3005225997
    FEI Number
    3005225997
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3260 Bayshore Blvd
    City
    BRISBANE
    State
    CA
    ZIP
    94005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221640

    Owner / Operator

    Firm Name
    CareDx, Inc.
    Operator Number
    9074467
    Address
    3260 BAYSHORE BOULEVARD, --
    City
    Brisbane
    State
    CA
    Postal Code
    94005
    Country
    US

    Products

    Device Name Product Code
    Cardiac Allograft Gene Expression Profiling Test System OJQ

    Proprietary Names

    AlloMap Heart

    Establishment Types

    Manufacture Medical Device