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 Code | NQF |
Regulation Number |
864.1860
|
Device Class |
3
|
Premarket Approvals (PMA) |
2019 |
2020 |
2021 |
2022 |
2023 |
2024 |
2
|
0
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0
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0
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0
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0
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