{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "ODV",
      "openfda": {
        "k_number": [
          "K071867"
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        "registration_number": [
          "3005406097"
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        "fei_number": [
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      "review_panel": "HE",
      "medical_specialty": "HE",
      "device_name": "Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Hematology",
      "device_class": "2",
      "definition": "An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.",
      "regulation_number": "864.7750",
      "implant_flag": "N",
      "submission_type_id": "1"
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}