NQFClass III

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

21 CFR 864.1860 / Hematology

NQF is the FDA product code for Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor, a class III device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: NQF
Device name: Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA 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: 21 CFR 864.1860
Device class: Class III
Review panel: Hematology
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NQF.

Recent clearances

Product code NQF

FDA records hold no clearances under product code NQF.

Recent recalls

Product code NQF

FDA records show no recalls under product code NQF.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)