{
  "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": "Ineligible",
      "product_code": "NSD",
      "openfda": {
        "pma_number": [
          "P030052"
        ],
        "registration_number": [
          "3005248192",
          "3019837962"
        ],
        "fei_number": [
          "3005248192",
          "3019837962"
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      },
      "review_panel": "PA",
      "medical_specialty": "",
      "device_name": "Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer.  It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}