{
  "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": "2026-07-20",
    "results": {
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      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
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      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QVU",
      "openfda": {
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      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Pathology",
      "device_class": "2",
      "definition": "A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only.",
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      "implant_flag": "N",
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