{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PHG",
      "openfda": {
        "registration_number": [
          "2915274",
          "3004013603",
          "3021269066"
        ],
        "fei_number": [
          "2915274",
          "3004013603",
          "3021269066"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "Droplet Digital Pcr System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "A droplet digital PCR system is an in vitro diagnostic amplification and detection test system that is intended for the amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from clinical specimens, which have been partitioned into nanoliter or smaller droplets using a water oil emulsion technique.  A droplet digital PCR system is intended for use with cleared or approved in vitro diagnostic assays  which specify its use.",
      "regulation_number": "862.2570",
      "implant_flag": "N",
      "submission_type_id": "4"
    }
  ]
}