BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    HemosIL AcuStar Anti-Cardiolipin IgG Controls

    Reg #: 3012348571 · FEI: 3012348571 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY SPA
    Registration Number
    3012348571
    FEI Number
    3012348571
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Leonardo da Vinci, 36
    City
    Roncello Lombardy
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K092181

    Owner / Operator

    Firm Name
    Instrumentation Laboratory SpA
    Operator Number
    10082968
    Address
    Viale Monza 338
    City
    Milan
    State
    Lombardy
    Postal Code
    20128
    Country
    IT
    Correspondent
    Natale Bova

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

    Establishment Types

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