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    Menarini Silicon Biosystems, Inc

    Manufacturer
    🇺🇸 United States

    Menarini Silicon Biosystems Inc.

    FDA registration
    Menarini Silicon Biosystems Inc.·5 products·🇺🇸 United States

    CELLTRACKS AUTOPREP

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000610·AutoPrep Instrument- Refurbished

    CELLTRACKS ANALYZER II

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000054·CellTracks Analyzer II

    CellSearch

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000016·Circulating Tumor Cell Kit (Epithelial)

    CELLTRACKS AUTOPREP

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000078·CellTracks AutoPrep Instrument Buffer

    CellSave

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000047·Preservative Tube 100 Pack

    CellSave

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000030·Preservative Tube 20 pack

    CELLTRACKS AUTOPREP

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000665·CELLTRACKS AUTOPREP - EU ROHS Compliant

    CellSearch

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000023·Circulating Tumor Cell Control Cell Kit

    CELLTRACKS ANALYZER II

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000627·CellTracks Analyzer II - Refurbished

    CELLTRACKS ANALYZER II

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000658·CELLTRACKS ANALYZER II - EU ROHS Compliant

    CELLTRACKS AUTOPREP

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000061·AutoPrep Instrument

    CELLTRACKS ANALYZER II

    FDA UDI
    MENARINI SILICON BIOSYSTEMS, INC.·10888385000085·Remote Review Work Station

    CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

    FDA Recall
    Open, Classified ·Menarini Silicon Biosystems·Product code NQI·May 20, 2022

    CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

    FDA Recall
    Terminated ·Menarini Silicon Biosystems·Product code NQI·April 4, 2018

    CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

    FDA Enforcement
    Class II ·Terminated·Menarini Silicon Biosystems·May 2, 2018

    CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

    FDA Enforcement
    Class II ·Ongoing·Menarini Silicon Biosystems·July 13, 2022

    Menarini Silicon Biosystems S.p.A.

    Authorized representative
    🇮🇹 Italy·1 Manufacturer