BEUDAMED
    FDA Registration Active 🇺🇸 United States

    i-STAT TBI Control Level 2

    Reg #: 2245578 · FEI: 2245578 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    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

    Regulatory Submissions

    510(k) Number
    K234143

    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
    Brain Trauma Assessment Test QAT

    Proprietary Names

    i-STAT TBI Control Level 2 i-STAT TBI cartridge i-STAT TBI Control Level 1 i-STAT TBI Calibration Verification Levels 1-3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility