{
  "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": "2026-04-13",
    "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": "PQA",
      "openfda": {
        "k_number": [
          "DEN160001",
          "K190472",
          "K221160",
          "K243725",
          "K212213",
          "K190452",
          "K223653",
          "K201017",
          "K231381",
          "K243345",
          "K191957"
        ],
        "registration_number": [
          "2243471",
          "3002444944",
          "1119779",
          "2024800",
          "3016838963",
          "3004530258",
          "3007923088",
          "3007420875"
        ],
        "fei_number": [
          "2243471",
          "3002444944",
          "1119779",
          "2024800",
          "3016838963",
          "3004530258",
          "3007923088",
          "3007420875"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.  The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.",
      "regulation_number": "866.3975",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}