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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeNQF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Regulation Number 864.1860
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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