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510(k) Data Aggregation

    K Number
    K101234
    Device Name
    VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
    Date Cleared
    2011-08-25

    (479 days)

    Product Code
    Regulation Number
    866.3110
    Why did this record match?
    Product Code :

    OWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (VENTANA anti-H. pylori (SP48)) is designed to qualitatively detect the presence of Helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of Helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.
    Device Description
    IHC in vitro diagnostic antibody directed against H. pylori organisms and visualized though the application of either of two standard chromogenic secondary detection kits to locate and bind primary antibodies bound to tissue samples. Use of either detection system results in a dark brown colored precipitate at the site of specific antibody binding.
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