{
  "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": "2026-11-02",
    "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": "QLT",
      "openfda": {
        "registration_number": [
          "3014214006",
          "3004141078",
          "1528450",
          "3013019728",
          "2024674",
          "2024800",
          "2243471",
          "3038610665",
          "3017638293"
        ],
        "fei_number": [
          "3014214006",
          "3004141078",
          "3013019728",
          "1000122536",
          "2024674",
          "2024800",
          "2243471",
          "3038610665",
          "3017638293"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "",
      "device_name": "Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices",
      "review_code": "",
      "unclassified_reason": "11",
      "medical_specialty_description": "Unknown",
      "device_class": "N",
      "definition": "Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "8"
    }
  ]
}