{
  "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": "Ineligible",
      "product_code": "QBN",
      "openfda": {
        "k_number": [
          "K212461",
          "K251495",
          "DEN170081",
          "K181412"
        ],
        "registration_number": [
          "1950204",
          "3010141591",
          "3002444944",
          "9615754",
          "3009288740",
          "3010191749",
          "1119779",
          "9615037"
        ],
        "fei_number": [
          "3003261083",
          "1950204",
          "3010141591",
          "3002444944",
          "3008237827",
          "3009288740",
          "3010191749",
          "1119779"
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      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens.    The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.",
      "regulation_number": "866.3378",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}