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510(k) Data Aggregation

    K Number
    K012960
    Device Name
    BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
    Manufacturer
    BIOGENEX LABORATORIES
    Date Cleared
    2002-03-08

    (185 days)

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

    BIOGENEX LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioGenex Mouse Monoclonal Anti-Progesterone Receptor Antibody (Clone PR88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human progesterone receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The PR88 antibody specifically binds to antigens located in the nucleus of cell populations that express progesterone receptor in normal and abnormal tissues. This antibody is indicated as an aid in assessing patient response to hormonal therapy and as an aid in the prognosis and management of breast cancer patients. 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
    BioGenex PR88 is a monoclonal antibody, which specifically binds to progesterone Dreceptor antigen located in the nuclear region of a variety of normal and abnormal tissues. It is a mouse monoclonal anti-progesterone receptor antibody from mouse ascites fluid diluted in phosphate buffered saline pH 7.6 containing bovine serum albumin as carrier and on and 0.09% sodium azide as preservative. The antibody is available in concentrated proximand 0.5970 bounds ready to use form (AM328-5M and AM328-10M). Refer to package insert for details.
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    K Number
    K013148
    Device Name
    BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
    Manufacturer
    BIOGENEX LABORATORIES
    Date Cleared
    2002-02-28

    (161 days)

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

    BIOGENEX LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioGenex Mouse Monoclonal Anti-Estrogen Receptor Antibody (Clone ER88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human estrogen receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The ER88 antibody specifically binds to antigens located in the nucleus of cell populations that express estrogen receptor in normal and abnormal tissues. This antibody is indicated as an aid in assessing patient response to hormonal therapy and as an aid in the prognosis and management of breast cancer patients. 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
    BioGenex ER88 is a monoclonal antibody, which specifically binds to estrogen receptor antigen located in the nuclear region of a variety of normal and abnormal tissues. It is a mouse monoclonal anti-estrogen receptor antibody from mouse ascites fluid diluted in phosphate buffered saline pH 7.6 containing bovine serum albumin as carrier protein and 0.09% sodium azide as preservative. The antibody is available in concentrated (MU368-UC) as well as ready to use form (AM368-5M and AM368-10M). Refer to package insert for details.
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