BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AmniSure ROM Test Positive and Negative Controls Pack

    Reg #: 1122376 · FEI: 3003572099 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    QIAGEN
    Registration Number
    1122376
    FEI Number
    3003572099
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    19300 Germantown Rd
    City
    Germantown
    State
    MD
    ZIP
    20874
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030849

    Owner / Operator

    Firm Name
    QIAGEN Sciences LLC
    Operator Number
    9002668
    Address
    19300 Germantown Road, --
    City
    Germantown
    State
    MD
    Postal Code
    20874
    Country
    US

    Products

    Device Name Product Code
    Immunoassay For Detection Of Amniotic Fluid Protein(S). NQM
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    AmniSure ROM Test Positive and Negative Controls Pack

    Establishment Types

    Manufacture Medical Device