BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Xprecia PrimeTM Coagulation Analyzer

    Reg #: 3007057632 · FEI: 3007057632 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    UNIVERSAL BIOSENSORS PTY LTD
    Registration Number
    3007057632
    FEI Number
    3007057632
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Corporate Avenue
    City
    Rovwille Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K151964

    Owner / Operator

    Firm Name
    Universal Biosensors Pty. Ltd.
    Operator Number
    10052962
    Address
    1 Corporate Avenue
    City
    Rovwille
    State
    Victoria
    Postal Code
    3178
    Country
    AU
    Correspondent
    Greeshma Kurella

    US Agent

    Business Name
    ZIVD LLC
    Contact Name
    Marcia Zucker
    Address
    62 Pollard Road, Plaistow, NH 03865
    City
    Plaistow
    State
    NH
    ZIP
    03865
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Test, Time, Prothrombin GJS
    Plasma, Coagulation Control GGN

    Proprietary Names

    Xprecia PrimeTM Coagulation Analyzer Xprecia PrimeTM PT/INR Test Strips XpreciaTM Systems PT Controls

    Establishment Types

    Manufacture Medical Device