{
  "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": "NQX",
      "openfda": {
        "k_number": [
          "K112937",
          "K070462",
          "K082140",
          "K130894",
          "K071026",
          "K033415",
          "K190771",
          "K132822",
          "K091409",
          "K101879",
          "K102740",
          "K243625",
          "K243070",
          "K100822",
          "K112424",
          "K093346",
          "K120138",
          "K080837",
          "K142721",
          "K162444",
          "K042357",
          "K191742",
          "K133605",
          "K132468"
        ],
        "registration_number": [
          "3003030793",
          "2243471",
          "1119779",
          "3003795116",
          "2024800",
          "1550222",
          "3016838963",
          "3004141078",
          "9610126",
          "3004530258",
          "3003540236",
          "3007420875"
        ],
        "fei_number": [
          "3003030793",
          "2243471",
          "1119779",
          "3003795116",
          "2024800",
          "3002806559",
          "1550222",
          "3016838963",
          "3004141078",
          "3004530258",
          "3003540236",
          "3007420875"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.",
      "regulation_number": "866.1640",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}