BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AlloMap Specimen Collection Kit

    Reg #: 3005225997 · FEI: 3005225997 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    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

    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
    Blood Specimen Collection Kit (Excludes Hiv Testing) OFZ

    Proprietary Names

    AlloMap Specimen Collection Kit HeartCare Specimen Collection Kit AlloSure Specimen collection kit KidneyCare Mobile Specimen Collection Kit KidneyCare Specimen Collection kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility