{
  "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": {
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      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
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      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
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      "definition": "A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection.",
      "regulation_number": "866.1655",
      "implant_flag": "N",
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}