{
  "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": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QJR",
      "openfda": {
        "registration_number": [
          "3011104381",
          "3002792284",
          "3003795116",
          "3013540184",
          "3007420875",
          "3003902721",
          "3017485950",
          "1063851",
          "3016608638",
          "3004146366",
          "3009875001",
          "3010607747",
          "2023365",
          "1221359",
          "3004141078",
          "2031468",
          "3014214006",
          "3004530258",
          "3009613136",
          "3014553740",
          "3038610665",
          "3024647994",
          "3008517993",
          "3005248192",
          "3003335080",
          "3004013603",
          "3016838963",
          "3010770794",
          "9615778",
          "2243471",
          "3003517954",
          "3009014878",
          "3016619649",
          "3009238284",
          "3012758946",
          "3016994837",
          "3012918440",
          "3024756665",
          "1524213",
          "2024800",
          "3009976420",
          "3010749841",
          "3009207631",
          "3013019728",
          "3008632402",
          "3032562",
          "3019837962",
          "1528450",
          "3013160357",
          "3017638293",
          "2032682",
          "3017358793",
          "9610126",
          "1119779",
          "3025663244"
        ],
        "fei_number": [
          "3011104381",
          "3002792284",
          "3003795116",
          "3013540184",
          "1000351505",
          "3007420875",
          "3003902721",
          "3017485950",
          "3002806559",
          "3016608638",
          "3004146366",
          "3009875001",
          "3010607747",
          "2023365",
          "1221359",
          "3004141078",
          "3014214006",
          "3004530258",
          "3009613136",
          "3014553740",
          "3038610665",
          "3024647994",
          "3008517993",
          "3005248192",
          "3003335080",
          "3004013603",
          "3016838963",
          "3010770794",
          "2243471",
          "3003517954",
          "3009014878",
          "3002023342",
          "3016619649",
          "3009238284",
          "3012758946",
          "3016994837",
          "3012918440",
          "3024756665",
          "1524213",
          "3002606748",
          "3003952975",
          "2024800",
          "3009976420",
          "3010749841",
          "3009207631",
          "3013019728",
          "3008632402",
          "1000122536",
          "3019837962",
          "3013160357",
          "3017638293",
          "3017358793",
          "1000442352",
          "1119779",
          "3025663244"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "",
      "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
      "review_code": "",
      "unclassified_reason": "11",
      "medical_specialty_description": "Unknown",
      "device_class": "N",
      "definition": "Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "8"
    }
  ]
}