{
  "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": "2026-08-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 28
    }
  },
  "results": [
    {
      "pma_number": "P160037",
      "supplement_number": "S028",
      "applicant": "Becton, Dickinson and Company",
      "street_1": "7loveton Cir.",
      "street_2": "",
      "city": "Sparks",
      "state": "MD",
      "zip": "21152",
      "zip_ext": "",
      "generic_name": "KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS",
      "trade_name": "BD Onclarity™ HPV Assay",
      "product_code": "MAQ",
      "advisory_committee": "MI",
      "advisory_committee_description": "Microbiology",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2026-05-22",
      "decision_date": "2026-08-14",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the extension of self-collected vaginal specimen transport and storage conditions for the BD Onclarity HPV Assay.",
      "openfda": {
        "registration_number": [
          "2243471",
          "3004141078",
          "2028492",
          "9610126",
          "1119779",
          "3003795116",
          "3019837962",
          "1122376",
          "2134567",
          "3005406097",
          "3005248192"
        ],
        "fei_number": [
          "3003572099",
          "2243471",
          "3004141078",
          "1119779",
          "3003795116",
          "3019837962",
          "3002622561",
          "3005406097",
          "1000125183",
          "3002806559",
          "3005248192"
        ],
        "device_name": "Kit, Dna Detection, Human Papillomavirus",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}