{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PMN",
      "openfda": {
        "k_number": [
          "K254167",
          "K230868",
          "K233611",
          "K191168",
          "K190222",
          "K173171",
          "K202382",
          "K260041",
          "DEN150058",
          "K161573",
          "K261475",
          "K152679",
          "K200010",
          "K241289",
          "K190086",
          "K212576",
          "K163522",
          "K181711",
          "K201403",
          "K202196",
          "K260577",
          "K191172",
          "K231221",
          "K251526",
          "K190223",
          "K190463",
          "K182472",
          "K181683",
          "K221253",
          "K203680",
          "K254166",
          "K231223"
        ],
        "registration_number": [
          "",
          "3005959679",
          "3010127294",
          "2016706",
          "2023365",
          "3010770794",
          "1528450",
          "2150138",
          "2024674",
          "1950302",
          "2024800"
        ],
        "fei_number": [
          "",
          "3005959679",
          "3010127294",
          "2016706",
          "2023365",
          "3010770794",
          "1000122536",
          "2150138",
          "2024674",
          "1950302",
          "2024800"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.",
      "regulation_number": "866.3920",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}