BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    i-STAT® Total ?-hCG Test

    Reg #: 3005643513 · FEI: 3005643513 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ABBOTT POINT OF CARE CANADA LIMITED
    Registration Number
    3005643513
    FEI Number
    3005643513
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    185 CORKSTOWN ROAD
    City
    Ottawa Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K133002

    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

    US Agent

    Business Name
    Abbott Point of Care
    Contact Name
    Jose Colon
    Address
    400 College Road East
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    609 4549356

    Products

    Device Name Product Code
    System, Test, Human Chorionic Gonadotropin DHA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    i-STAT® Total ?-hCG Test

    Establishment Types

    Manufacture Medical Device