{
  "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": "SEI",
      "openfda": {
        "k_number": [
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          "K260046",
          "K260049",
          "K253687"
        ],
        "pma_number": [
          "P050048",
          "P190005",
          "P180038",
          "P110022",
          "P010053",
          "P000014",
          "P010051",
          "P180045",
          "P110025",
          "P190034",
          "P030026",
          "P010054",
          "P050051",
          "P100032",
          "P060034",
          "P100001",
          "P060031",
          "P180039",
          "P080023",
          "P060035",
          "P180049",
          "P100031",
          "P110031",
          "P200017",
          "P210019",
          "P030040",
          "P030024",
          "P100039",
          "P040004",
          "P010052"
        ],
        "registration_number": [
          "1319681",
          "3000308930",
          "3008344661",
          "2250051",
          "3007111389",
          "3032705",
          "9610126",
          "9610240",
          "1219913",
          "3002642396",
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          "9610746",
          "3012963943",
          "9680746",
          "3002806944",
          "2432235",
          "8023018"
        ],
        "fei_number": [
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          "3008344661",
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          "3007111389",
          "1000206808",
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          "3002806557",
          "3002806944",
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          "3002701146"
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      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Qualitative And Quantitative Hepatitis B Virus Antibody Assays",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.",
      "regulation_number": "866.3173",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}