BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alinity i STAT CK-MB Controls (LN 04V3810)

    Reg #: 2245578 · FEI: 2245578 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABBOTT POINT OF CARE INC.
    Registration Number
    2245578
    FEI Number
    2245578
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    400 College Road East
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US

    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
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    Alinity i STAT CK-MB Controls (LN 04V3810) Alinity c CRP Vario HS Control Kit (LN 07P5612) Alinity i STAT Myoglobin Controls (LN 04V3710) Alinity c Proteins Control Kit (LN 08P6712) Alinity i Anti-CCP Controls (LN 09P2710) i-STAT TBI Calibration Verification i-STAT TBI Controls i-STAT hs-TnI Control Level 2 i-STAT hs-TnI Control Level 3 i-STAT hs-TnI Control Level 1 i-STAT hs-TnI Calibration Verification Levels 1-3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198