{
  "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": {
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      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "PQV",
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      "device_name": "ß-Glucocerebrosidase (Gba) Newborn Screening Test System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "For quantitative measurement of the activity of ß-glucocerebrosidase (GBA)  from newborn dried blood spot specimens.",
      "regulation_number": "862.1488",
      "implant_flag": "N",
      "submission_type_id": "1"
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}