BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Atellica CH Fructosamine (Fruc)

    Reg #: 3004493545 · FEI: 3004493545 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RANDOX LABORATORIES LIMITED
    Registration Number
    3004493545
    FEI Number
    3004493545
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    36 / 44 LARGY ROAD
    City
    CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K131307

    Owner / Operator

    Firm Name
    RANDOX LABORATORIES, LTD.
    Operator Number
    8020890
    Address
    55 DIAMOND RD., --
    City
    CRUMLIN, CO.ANTRIM
    State
    GB-NOTA
    Postal Code
    BT29 4QY
    Country
    GB
    Correspondent
    Karena - Shaw

    US Agent

    Business Name
    RANDOX LABORATORIES-US, LTD
    Contact Name
    Sammy Alnajm
    Address
    515 Industrial Boulevard
    City
    Kearneysville
    State
    WV
    ZIP
    25430
    Country
    US
    Email
    [email protected]
    Phone
    304 7282890

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Assay, Glycosylated Hemoglobin LCP

    Proprietary Names

    Atellica CH Fructosamine (Fruc) Atellica CH Fructosamine Calibrator ADVIA Chemistry Fructosamine Calibrator ADVIA Chemistry Fructosamine Reagent

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)