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510(k) Data Aggregation

    K Number
    K984567
    Device Name
    VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
    Manufacturer
    VENTANA, INC.
    Date Cleared
    1999-08-12

    (232 days)

    Product Code
    MYA
    Regulation Number
    864.1860
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    Applicant Name (Manufacturer) :

    VENTANA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ventana Medical Systems' ER Primary Antibody (Clone 6F11) may be used in immunohistochemical methods to aid in the identification of estrogen receptor (ER) antigen in normal and neoplastic cells as an aid in the diagnosis of ER positive tumors. The anti-ER (Clone 6F11) is intended for laboratory use to qualitatively stain ER antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide staining device. It is further intended as an aid in the assessment of prognosis in the evaluation of breast cancer. Detection chemistries used by Ventana to detect ER are DAB, AEC, Alkaline phosphatase red and blue. Light microscopy is used to detect the staining of cell components. It is indicated for use in the management, prognosis and prediction of therapy outcome of breast cancer.
    Device Description
    Ventana's ER Primary Antibody (clone 6F11) is a monoclonal antibody which specifically binds to estrogen receptor antigen located in the nuclear region of a variety of normal and neoplastic tissues. The dispenser contains approximately 5 ug (50 test) or 25 ug (250 test) of mouse anti-human ER monoclonal antibody. The total protein concentration of the reagent is approximately 1 mg/ml. Specific antibody concentration is approximately 1 ug/ml. Clone 6F11 is immunoglobulin class IgG, light chain kappa. There is no known irrelevant antibody in the preparation.
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