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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device immunohistochemistry assay, antibody, epidermal growth factor receptor
Regulation Description Immunohistochemistry reagents and kits.
Definition The epidermal growth factor receptor (EGFR) antibody/assay is a qualitative immunohistochemical antibody/assay to identify EGFR expression in normal and neoplastic tissues routinely-fixed for histological evaluation. EGFR antibody/assay specifically detects the EGFR (HER1) protein in EGFR-expressing cells. This antibody/assay is indicated as an aid in identifying colorectal cancer patients eligible for treatment with cetuximab, a monoclonal antibody drug. This will be a specialized subcategory for EGFR immunohistochemistry assays under the general heading of the regulation for all Immunohistochemistry assays.
Product CodeNQF
Regulation Number 864.1860
Device Class 3