{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NTI",
      "openfda": {
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          "K131565",
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          "K043576",
          "K101683",
          "K123891",
          "K170492",
          "DEN040011",
          "K051824",
          "K093420",
          "K130189"
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          "3021047648",
          "3005406097"
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      "review_panel": "TX",
      "medical_specialty": "TX",
      "device_name": "Drug Metabolizing Enzyme Genotyping Systems",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Toxicology",
      "device_class": "2",
      "definition": "Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.",
      "regulation_number": "862.3360",
      "implant_flag": "N",
      "submission_type_id": "1"
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}