{
  "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": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PHJ",
      "openfda": {
        "k_number": [
          "K132978"
        ]
      },
      "review_panel": "PA",
      "medical_specialty": "HE",
      "device_name": "System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Hematology",
      "device_class": "2",
      "definition": "A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry.  It is intended as an aid in diagnosis of patients with suspected thrombophilia.",
      "regulation_number": "864.7280",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}