BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Access AccuTnI +3 for use on the UniCel DxI Immunoassay Systems. (P/N: A98264)

    Reg #: 2122870 · FEI: 2122870 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    2122870
    FEI Number
    2122870
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1000 LAKE HAZELTINE DR.
    City
    CHASKA
    State
    MN
    ZIP
    55318
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121790

    Owner / Operator

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

    Products

    Device Name Product Code
    Immunoassay Method, Troponin Subunit MMI
    Calibrator, Secondary JIT
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Access AccuTnI +3 for use on the UniCel DxI Immunoassay Systems. (P/N: A98264) UniCel DxI 800 Access Immunoassay System w/ Dual Gantry (P/N: A71457) UniCel DxI 600 Access Immunoassay System w/ Dual Gantry (P/N: A71461) UniCel DxI 600 Access Immunoassay System (P/N: A30260) UniCel DxI 800 Access Immunoassay System (P/N: 973100) Access AccuTnI +3 Calibrators for use on the UniCel DxI Immunoassay Systems.(P/N: A98265) UniCel DxI 600 Access Immunoassay System w/ Spot B Gantry (P/N: A71460) UniCel DxI 800 Access Immunoassay System w/ Spot B Gantry (P/N: A71456)

    Establishment Types

    Manufacture Medical Device