{
  "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": "2026-07-27",
    "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": "Eligible",
      "product_code": "PSU",
      "openfda": {
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      "review_panel": "PA",
      "medical_specialty": "MG",
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      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Medical Genetics",
      "device_class": "2",
      "definition": "The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene.  It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors.",
      "regulation_number": "866.6070",
      "implant_flag": "N",
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}