BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls

    Reg #: 3012775350 · FEI: 3012775350 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Instrumentation Laboratory Co.
    Registration Number
    3012775350
    FEI Number
    3012775350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    18B Independence Dr
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091556

    Owner / Operator

    Firm Name
    Instrumentation Laboratory Co.
    Operator Number
    1217183
    Address
    180 Hartwell Road, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Carol - Marble

    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 IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG HemosIL AcuStar Anti-B2 Glycoprotein-I IgM HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls

    Establishment Types

    Repack or Relabel Medical Device Manufacture Device in the United States for Export Only