BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    HemosIL AcuStar Anti-B2 Glycoprotein-I IgM

    Reg #: 3012348571 · FEI: 3012348571 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    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
    K091556

    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,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV

    Proprietary Names

    HemosIL AcuStar Anti-B2 Glycoprotein-I IgM HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG QUANTA Flash B2GP1 IgG Reagents QUANTA Flash B2GP1 IgM QUANTA Flash B2GP1 IgM Controls QUANTA Flash B2GP1 IgM Reagents QUANTA Flash B2GP1 IgG QUANTA Flash B2GP1 IgG Controls

    Establishment Types

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