{
  "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": "ODW",
      "openfda": {
        "k_number": [
          "K073720",
          "K070804",
          "K073014",
          "K183530",
          "K073071",
          "K152612"
        ],
        "registration_number": [
          "3005406097"
        ],
        "fei_number": [
          "3005406097"
        ]
      },
      "review_panel": "TX",
      "medical_specialty": "TX",
      "device_name": "Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Toxicology",
      "device_class": "2",
      "definition": "An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles.  Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.",
      "regulation_number": "862.3360",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}