BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    QUANTIA IgE

    Reg #: 9610746 · FEI: 3002806557 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    3
    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
    K050493

    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
    Controls For Blood-Gases, (Assayed And Unassayed) JJS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Ige, Antigen, Antiserum, Control DGC

    Proprietary Names

    QUANTIA IgE QUANTIA IgE / Ferritin / Myoglobin Control QUANTIA IgE Calibrator Alinity c Ferritin/IgE/Myoglobin Control Kit Alinity c IgE Calibrators

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device