BEUDAMED
    FDA Registration Active 🇺🇸 United States

    439715 Direct Bilirubin Reagent (DBIL 2 x 200)

    Reg #: 2050010 · FEI: 2050010 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    2050010
    FEI Number
    2050010
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2470 Faraday Ave
    City
    CARLSBAD
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K934068

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US

    Products

    Device Name Product Code
    Diazo Colorimetry, Bilirubin CIG
    Calibrator, Primary JIS

    Proprietary Names

    439715 Direct Bilirubin Reagent (DBIL 2 x 200) 465915 SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR 476856 Direct Bilirubin Reagent (DBIL 2 x 300)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)