BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DIRECT BILIRUBIN (LN 8G63-21, 8G63-22)

    Reg #: 3016438761 · FEI: 3016438761 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ABBOTT LABORATORIES
    Registration Number
    3016438761
    FEI Number
    3016438761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1915 Hurd Drive
    City
    Irving
    State
    TX
    ZIP
    75038
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022180

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Diazo Colorimetry, Bilirubin CIG

    Proprietary Names

    DIRECT BILIRUBIN (LN 8G63-21, 8G63-22) Alinity c Direct Bilirubin Reagent Kit (LN 07P9720)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility