{
  "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": "Ineligible",
      "product_code": "QMI",
      "openfda": {
        "k_number": [
          "K241921",
          "K202215"
        ],
        "registration_number": [
          "3019837962",
          "2243471",
          "3003795116",
          "3004141078",
          "3005248192"
        ],
        "fei_number": [
          "3019837962",
          "2243471",
          "3003795116",
          "3004141078",
          "3005248192"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. Test results are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions.",
      "regulation_number": "866.3183",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}