BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CareDx, Inc.

    Reg #: 3005225997 · FEI: 3005225997 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    CareDx, Inc.
    Registration Number
    3005225997
    FEI Number
    3005225997
    Status
    Active
    Expiry Year
    2026
    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
    Blood Specimen Collection Kit (Excludes Hiv Testing) OFZ
    Cardiac Allograft Gene Expression Profiling Test System OJQ
    General Purpose Reagent PPM

    Proprietary Names

    AlloSure Specimen collection kit HeartCare Specimen Collection Kit AlloMap Specimen Collection Kit KidneyCare Mobile Specimen Collection Kit KidneyCare Specimen Collection kit AlloMap Heart PROCESSING PACK ALLOMAP SAMPLE COLLECTION

    Establishment Types

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