{
  "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": "PAB",
      "openfda": {
        "k_number": [
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          "K243485",
          "K252481"
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        "pma_number": [
          "P210022",
          "P210029",
          "P160044",
          "P110037",
          "P130027",
          "P160041"
        ],
        "registration_number": [
          "3019837962",
          "2243471",
          "3003795116",
          "2024800",
          "2023365",
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      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Cytomegalovirus (Cmv) Dna Quantitative Assay",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.",
      "regulation_number": "866.3180",
      "implant_flag": "N",
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}