BEUDAMED
    FDA Registration Active 🇺🇸 United States

    POMC/PCSK1/LEPR CDx Panel

    Reg #: 3010863263 · FEI: 3010863263 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PreventionGenetics, LLC.
    Registration Number
    3010863263
    FEI Number
    3010863263
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3800 S Business Park Ave
    City
    Marshfield
    State
    WI
    ZIP
    54449
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN200059

    Owner / Operator

    Firm Name
    Exact Sciences Corporation
    Operator Number
    10047364
    Address
    5505 Endeavor Lane
    City
    Madison
    State
    WI
    Postal Code
    53719
    Country
    US
    Correspondent
    Ashlie Rodriguez

    Products

    Device Name Product Code
    Setmelanotide Eligibility Gene Variant Detection System QRV

    Proprietary Names

    POMC/PCSK1/LEPR CDx Panel

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device