BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    HemosIL AcuStar Anti-Cardiolipin IgG

    Reg #: 9610746 · FEI: 3002806557 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    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
    K092181

    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Anticardiolipin Immunological MID

    Proprietary Names

    HemosIL AcuStar Anti-Cardiolipin IgG QUANTA Flash aCL IgG HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgM QUANTA Flash aCL IgM Controls QUANTA Flash aCL IgG Controls QUANTA Flash aCL IgM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)