{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "NQF",
      "openfda": {
        "pma_number": [
          "P030044"
        ]
      },
      "review_panel": "PA",
      "medical_specialty": "HE",
      "device_name": "Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Hematology",
      "device_class": "3",
      "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_number": "864.1860",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}