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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
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

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 1 2 2 0 0 0 0 0

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoxia 1 1
Respiratory Distress 1 1

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