{
  "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": "2026-04-13",
    "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": "PCH",
      "openfda": {
        "k_number": [
          "K121894",
          "K190585",
          "K140377",
          "K191161",
          "K142033",
          "K254032",
          "K143648",
          "K140407",
          "K242367",
          "K251868",
          "K160459",
          "K232672",
          "K170308",
          "K142501",
          "K220607",
          "DEN130003",
          "K243885",
          "K140647",
          "K220193",
          "K251993",
          "K183023",
          "K143005",
          "K152955",
          "K123274",
          "K220062",
          "K251721",
          "K140083",
          "K252329",
          "K243813",
          "K181427",
          "K183030",
          "K230404",
          "K242877",
          "K180041",
          "K250324",
          "K191160",
          "K182703"
        ],
        "registration_number": [
          "3002777243",
          "3002773840",
          "3009613136",
          "1119779",
          "2024800",
          "3007420875",
          "3011781554",
          "1650733",
          "3016838963",
          "3005360469",
          "3004013603",
          "3006028115",
          "3004530258",
          "3007799234",
          "3010749841",
          "3014553740"
        ],
        "fei_number": [
          "3002777243",
          "3002773840",
          "3009613136",
          "1119779",
          "2024800",
          "3007420875",
          "3011781554",
          "3005670738",
          "3016838963",
          "3004013603",
          "3006028115",
          "3004530258",
          "3007799234",
          "3010749841",
          "3002524000",
          "3014553740"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.",
      "regulation_number": "866.3990",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}