{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QID",
      "openfda": {
        "k_number": [
          "DEN190025"
        ],
        "registration_number": [
          "3003297763",
          "3004142665",
          "3022474803"
        ],
        "fei_number": [
          "3003297763",
          "3004142665",
          "3022474803"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure.  Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.",
      "regulation_number": "866.4002",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}