BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Atellica CH TDM Calibrators (TDM CAL)

    Reg #: 3004493545 · FEI: 3004493545 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    5

    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
    K992662

    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
    System, Test, C-Reactive Protein DCN
    Enzymatic, Carbon-Dioxide KHS
    Immunochemical, Transferrin JNM
    Apolipoproteins MSJ
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN

    Proprietary Names

    Atellica CH TDM Calibrators (TDM CAL) Atellica CH Immunoglobulin G_2 (IgG_2) Atellica CH Immunoglobulin M_2 (IgM_2) Atellica CH Transferrin (Trf) Atellica CH Immunoglobulin A_2 (IgA_2)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)