BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    ARCHITECT 2nd Generation Testosterone

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

    Regulatory Submissions

    510(k) Number
    K152155

    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
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ

    Proprietary Names

    ARCHITECT 2nd Generation Testosterone Alinity i 2nd Generation Testosterone Reagent Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)