{
  "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": "NIJ",
      "openfda": {
        "k_number": [
          "K123753",
          "K092953",
          "K102416",
          "K243405",
          "K061686",
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      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp.  as a marker for vancomycin resistance using DNA probe technology",
      "regulation_number": "866.1640",
      "implant_flag": "N",
      "submission_type_id": "1"
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}