Pathway HER-2/NEU (Clone CB11) Primary Antibody

This antibody is designed for **laboratory use in immunohistochemistry (IHC)** to semi-quantitatively detect the **c-ERBB-2 antigen** in formalin-fixed, paraffin-embedded tissue samples—both normal and cancerous. It helps pathologists assess **HER-2/neu expression levels** in breast cancer patients, which is critical for determining eligibility for **HERCEPTIN treatment** (trastuzumab). The assay aids in treatment decision-making by evaluating protein overexpression linked to tumor behavior.

The antibody is supplied as a **reagent** specifically for use on **Ventana automated immunohistochemistry slide staining systems**. It is intended for **single-use only** in a laboratory setting and does not require additional sterilization beyond standard reagent handling. The automated system ensures consistent staining of tissue sections, while the antibody itself is not a physical device—it is a diagnostic reagent designed to bind to HER-2/neu proteins in prepared slides.

This antibody is **intended for single-use only** in a laboratory setting. As a reagent, it is not designed to withstand repeated use or sterilization processes. Laboratories must follow standard reagent handling protocols to ensure accuracy and prevent cross-contamination, as reuse could compromise test reliability or introduce errors in HER-2/neu detection.

The antibody holds a **Premarket Approval (PMA)** designation from the FDA (PMA Number: **P990081**), classifying it as a **Class III medical device**. This designation reflects its role in diagnosing conditions that substantially affect patient health—specifically, guiding treatment decisions for breast cancer via HER-2/neu assessment. The approval process ensures its safety, effectiveness, and performance for its intended use in immunohistochemistry.

While the provided data does not specify exact storage conditions, **monoclonal antibodies like this one typically require refrigeration (2–8°C)** to maintain stability and efficacy. Laboratories should consult the included **Instructions for Use (IFU)** or manufacturer guidelines for precise storage instructions, including protection from light and freeze-thaw cycles, to preserve the reagent’s integrity for accurate HER-2/neu detection in tissue samples.