BEUDAMED
    FDA Registration Active 🇺🇸 United States

    myChoice CDx

    Reg #: 3030654068 · FEI: 3030654068 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MYRIAD GENETIC LABORATORIES, INC.
    Registration Number
    3030654068
    FEI Number
    3030654068
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    322 N 2200 W
    City
    Salt Lake City
    State
    UT
    ZIP
    84116
    Country
    US

    Regulatory Submissions

    PMA Number
    P190014

    Owner / Operator

    Firm Name
    Myriad Genetic Laboratories, Inc.
    Operator Number
    10048417
    Address
    320 Wakara Way
    City
    Salt Lake City
    State
    UT
    Postal Code
    84108
    Country
    US
    Correspondent
    Rebekah J Miller

    Products

    Device Name Product Code
    Cancer-Related Germline Gene Mutation Detection System PJG
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System PQP

    Proprietary Names

    myChoice CDx

    Establishment Types

    Manufacture Medical Device