{
  "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": "MKT",
      "openfda": {
        "pma_number": [
          "P170025",
          "P150014",
          "P050028",
          "P200013",
          "P080026"
        ],
        "registration_number": [
          "3025663244",
          "3004141078",
          "3003795116",
          "3005248192",
          "3019837962",
          "2024800",
          "9610126",
          "2243471",
          "3012322232"
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          "3012322232"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Hepatitis Viral B Dna Detection",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.  The test results must be interpreted within the context of all relevant clinical and laboratory findings.",
      "regulation_number": "866.3174",
      "implant_flag": "N",
      "submission_type_id": "1"
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  ]
}