BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    QUANTA Flash aCL IgA Controls

    Reg #: 9610746 · FEI: 3002806557 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    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
    K120817

    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
    System, Test, Anticardiolipin Immunological MID
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    QUANTA Flash aCL IgA Controls QUANTA Flash B2GP1 IgA Controls QUANTA Flash aCL IgA QUANTA Flash B2GP1 IgA

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)