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EGFR PharmDx Assay Kit

FDA PMA

Class III (US FDA PMA)

PMA P030044

by Agilent Technologies, Inc.

Identity

Trade Name
DAKOCYTOMATION EGFR PHARMDX FDA PMA
Generic Name
Immunohistochemistry assay, antibody, epidermal growth factor receptor FDA PMA

Identifiers

PMA Number
P030044 FDA PMA
FDA Product Code
NQF FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 864.1860 FDA PMA
Regulation Number
864.1860 FDA PMA
Advisory Committee
Pathology FDA PMA
FDA Decision
APWD FDA PMA

The EGFR PharmDx is a qualitative immunohistochemistry (IHC) kit system designed to detect epidermal growth factor receptor (EGFR, HER1) protein expression in formalin-fixed, paraffin-embedded (FFPE) tissue samples. It is classified as an immunohistochemistry assay, antibody-based diagnostic device and is intended for use in pathology laboratories to evaluate EGFR expression in both normal and neoplastic tissues, including colorectal cancer specimens.

This assay is supplied as a single-use reagent kit and requires laboratory processing, including tissue preparation, staining, and microscopic examination. It is regulated under FDA Premarket Approval (PMA) with approval number P030044, and is categorized under device class III (864.1860) for hematology applications. Storage and handling must comply with standard IHC assay protocols to ensure accuracy and reliability of EGFR detection for treatment eligibility determination in eligible patients.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Agilent Technologies, Inc.

Sources (1)

  • FDA PMA P030044 24 fields · synced Sep 18, 2026