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For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the En Vision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds progesterone receptor-expressing cells and is useful in the assessment of progesterone receptor status in human breast carcinomas. 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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Readyto-Use (Dako Omnis) is utilized to perform a qualitative immunohistochemical (IHC) assay to identify progesterone receptor (PR) expression in formalin fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The proposed device is a variant of FLEX Monoclonal Mouse Anti-Human Progesterone Receptor intended for use with the automated slide staining instrument Dako Omnis. The design of the proposed device is developed to provide equivalent performance to its predicate FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) with adaptation of the product configuration, to be used on the Dako Omnis Instrument instead of the Autostainer Link 48 Instrument. The antibody is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The proposed device is intended for automated immunohistochemical (IHC) slide staining with the Dako Omnis Instrument and the software performing and controlling the automated slide staining process is validated for its intended use.

For in vitro diagnostic use. FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the EnVision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds estrogen receptor a expressing cells and is useful in the assessment of estrogen receptor status in human breast carcinomas. 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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.

The FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis) antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The design of the proposed device is based on the design of its predicate FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α. Clone EP1, Ready-to-Use (Link) with adaptation of the product configuration, to be used on the Dako Omnis Instrument instead of the Autostainer Link 48 Instrument. The antibody is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The antibody is intended for automated immunohistochemical (IHC) slide staining with the Dako Omnis Instrument and the software performing and controlling the automated slide staining process is validated for its intended use.