{
  "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": "Eligible",
      "product_code": "PII",
      "openfda": {
        "k_number": [
          "DEN140019",
          "K234063",
          "K173536"
        ],
        "registration_number": [
          "3010749841",
          "1627497",
          "3004613294"
        ],
        "fei_number": [
          "3010749841",
          "1627497",
          "3004613294"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Candida Species Nucleic Acid Detection System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections.  The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.",
      "regulation_number": "866.3960",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}