BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Alinity I 2nd Generation Testosterone Calibrators

    Reg #: 8032314 · FEI: 3002808140 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AXIS-SHIELD DIAGNOSTICS, LTD.
    Registration Number
    8032314
    FEI Number
    3002808140
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LUNA PLACE, THE TECHNOLOGY PARK
    City
    DUNDEE Scotland
    Country
    GB

    Owner / Operator

    Firm Name
    AXIS-SHIELD DIAGNOSTICS, LTD.
    Operator Number
    8032314
    Address
    LUNA PLACE, THE TECHNOLOGY PARK
    City
    DUNDEE, SCOTLAND
    State
    GB-NOTA
    Postal Code
    DD2 1XA
    Country
    GB
    Correspondent
    CLAIRE - DORA

    US Agent

    Business Name
    Abbott Laboratories
    Contact Name
    Danial Kirmani
    Address
    Dept. Rx51/J55/Ms 6134, 100 Abbott Park Rd
    City
    North Chicago
    State
    IL
    ZIP
    60064
    Country
    US
    Email
    [email protected]
    Phone
    224 6686318

    Products

    Device Name Product Code
    Calibrator, Secondary JIT

    Proprietary Names

    Alinity I 2nd Generation Testosterone Calibrators Alinity i Active-B12 (Holotranscobalamin) Calibrators AFINION™ HbA1c Calibration Verification

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device