BEUDAMED
    FDA Registration Active 🇺🇸 United States

    4Kscore Test

    Reg #: 3003652672 · FEI: 3003652672 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BioReference Health, LLC
    Registration Number
    3003652672
    FEI Number
    3003652672
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    481 Edward H. Ross Drive
    City
    Elmwood Park
    State
    NJ
    ZIP
    07407
    Country
    US

    Regulatory Submissions

    PMA Number
    P190022

    Owner / Operator

    Firm Name
    OPKO Health, Inc.
    Operator Number
    10059750
    Address
    4400 Biscayne Boulevard
    City
    Miami
    State
    FL
    Postal Code
    33137
    Country
    US

    Products

    Device Name Product Code
    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer QRF

    Proprietary Names

    4Kscore Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device