{
  "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": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NPR",
      "openfda": {
        "k_number": [
          "K100943",
          "K223046",
          "K033612",
          "K172913",
          "K250218"
        ],
        "registration_number": [
          "3005406097",
          "3004530258",
          "2243471",
          "3016838963"
        ],
        "fei_number": [
          "3005406097",
          "3004530258",
          "2243471",
          "3016838963"
        ]
      },
      "review_panel": "PA",
      "medical_specialty": "HE",
      "device_name": "Test, Factor Ii G20210a Mutations, Genomic Dna Pcr",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Hematology",
      "device_class": "2",
      "definition": "In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.",
      "regulation_number": "864.7280",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}