{
  "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,
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  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "PMI",
      "openfda": {},
      "review_panel": "MG",
      "medical_specialty": "",
      "device_name": "Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate.",
      "regulation_number": "",
      "implant_flag": "N",
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}