{
  "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": "Eligible",
      "product_code": "OUL",
      "openfda": {
        "registration_number": [
          "3003673482",
          "3016635427",
          "3009155756",
          "3027645317",
          "3010420046",
          "3015505238",
          "3010030414"
        ],
        "fei_number": [
          "3003673482",
          "3016635427",
          "3009155756",
          "3027645317",
          "3010420046",
          "3015505238",
          "3010030414"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "Thermocycler, Generic",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "1",
      "definition": "A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run.  It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats.",
      "regulation_number": "862.2310",
      "implant_flag": "N",
      "submission_type_id": "4"
    }
  ]
}