{
  "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": "OUE",
      "openfda": {
        "registration_number": [
          "3003419906",
          "3003522182",
          "3005625991",
          "2155"
        ],
        "fei_number": [
          "3003419906",
          "3003522182",
          "3005625991",
          "2155"
        ]
      },
      "review_panel": "IM",
      "medical_specialty": "CH",
      "device_name": "Micro Total Analysis Instrument System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip.  Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector.  It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.",
      "regulation_number": "862.2570",
      "implant_flag": "N",
      "submission_type_id": "4"
    }
  ]
}