{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SCX",
      "openfda": {
        "k_number": [
          "K240041"
        ],
        "registration_number": [
          "3013960814"
        ],
        "fei_number": [
          "3013960814"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Immunoassay For Host Biomarkers Of Sepsis",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.",
      "regulation_number": "866.3215",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}