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510(k) Data Aggregation

    K Number
    K183100
    Device Name
    Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
    Manufacturer
    Leica Biosystems Newcastle Limited
    Date Cleared
    2018-12-07

    (30 days)

    Product Code
    MYA
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Leica Biosystems Newcastle Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells. Estrogen Receptor Clone 6F11 is indicated as an aid in the management, prognosis and predication of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™ and the Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra™ are optimized for use on the Leica Biosystems Bond III staining platform using the Bond Polymer Refine Detection Kit.
    Device Description
    Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.
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    K Number
    K183102
    Device Name
    BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
    Manufacturer
    Leica Biosystems Newcastle Limited
    Date Cleared
    2018-12-07

    (30 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Leica Biosystems Newcastle Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ready-to-Use Format Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells. PR (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. Concentrated Liquid Antibody Format. Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells. PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context's clinical history and other diagnostic tests by a qualified pathologist.
    Device Description
    Not Found
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    K Number
    K171753
    Device Name
    BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
    Manufacturer
    Leica Biosystems Newcastle Limited
    Date Cleared
    2017-07-21

    (39 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Leica Biosystems Newcastle Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ready-to-Use Format: Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BONDMAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells. PR (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. Concentrated Liquid Antibody Format: Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells. PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
    Device Description
    Not Found
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