{
  "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": "2026-11-02",
    "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": "PHK",
      "openfda": {
        "registration_number": [
          "3009099956"
        ],
        "fei_number": [
          "3009099956"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "",
      "device_name": "Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation",
      "review_code": "",
      "unclassified_reason": "9",
      "medical_specialty_description": "Unknown",
      "device_class": "N",
      "definition": "The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "6"
    }
  ]
}