BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Cystatin C Control Set

    Reg #: 3013059683 · FEI: 3013059683 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ATSI Logistics Center ApS
    Registration Number
    3013059683
    FEI Number
    3013059683
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    42 PRODUKTIONSVEJ, --
    City
    GLOSTRUP Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K041627

    Owner / Operator

    Firm Name
    Agilent Technologies, Inc
    Operator Number
    10038794
    Address
    5301 Stevens Creek Blvd
    City
    Santa Clara
    State
    CA
    Postal Code
    95051
    Country
    US
    Correspondent
    Widad Ghaben

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Test, Cystatin C NDY

    Proprietary Names

    Cystatin C Control Set

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device