BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STA - Multi Hep Calibrator

    Reg #: 2245451 · FEI: 2245451 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DIAGNOSTICA STAGO, INC.
    Registration Number
    2245451
    FEI Number
    2245451
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5 Century Dr
    City
    PARSIPPANY
    State
    NJ
    ZIP
    07054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111822

    Owner / Operator

    Firm Name
    Diagnostica Stago, Inc.
    Operator Number
    9003476
    Address
    5 Century Drive, Sute 200
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    Plasma, Coagulation Control GGN
    Assay, Heparin KFF

    Proprietary Names

    STA - Multi Hep Calibrator STA - Quality HBPM/LMWH STA - Quality HNF/UFH STA - Liquid Anti-Xa 4 STA - Liquid Anti-Xa 8

    Establishment Types

    Manufacture Medical Device