BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Menarini Silicon Biosystems Inc.

    Reg #: 3004153557 · FEI: 3004153557 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    Menarini Silicon Biosystems Inc.
    Registration Number
    3004153557
    FEI Number
    3004153557
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3401 Masons Mill road, Suite 100
    City
    Huntingdon Valley
    State
    PA
    ZIP
    19006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030596

    Owner / Operator

    Firm Name
    Menarini Silicon Biosystems Inc.
    Operator Number
    10054393
    Address
    3401 Masons Mill Road, Suite 100
    City
    Huntingdon Valley
    State
    PA
    Postal Code
    19006
    Country
    US
    Correspondent
    Thomas Johnson

    Products

    Device Name Product Code
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Apparatus, Automated Blood Cell Diluting GKH
    System, Immunomagnetic, Circulating Cancer Cell, Enumeration NQI
    Control Material, Blood Circulating Epithelial Cancer Cell NRS
    Reagents, Specific, Analyte MVU

    Proprietary Names

    CellSearch Collection Kit CellSearch AutoPrep Samples Prep system CellSearch CTC Enumeration System CellSearch CTC Control Kit CellSearch CTC Kit CellSearch Reagent CellSearch CellTracks Analyzer II

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device