BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Alinity i SHBG Controls

    Reg #: 9610746 · FEI: 3002806557 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BIOKIT S.A.
    Registration Number
    9610746
    FEI Number
    3002806557
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AV. CAN MONTCAU 7
    City
    LLISSA D AMUNT Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K060818

    Owner / Operator

    Firm Name
    BIOKIT S.A.
    Operator Number
    8030752
    Address
    AV CAN MONTCAU, 7, --
    City
    LLISSA D'AMUNT, BARCELONA
    State
    ES-B
    Postal Code
    08186
    Country
    ES
    Correspondent
    ANGELS - ROMA

    Products

    Device Name Product Code
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT

    Proprietary Names

    Alinity i SHBG Controls Alinity i SHBG Reagent Kit Alinity i SHBG Calibrators ARCHITECT SHBG ARCHITECT SHBG Controls ARCHITECT SHBG Calibrators

    Establishment Types

    Manufacture Medical Device