{
  "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": "QLW",
      "openfda": {
        "registration_number": [
          "2321034",
          "3005174594",
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      "review_panel": "MI",
      "medical_specialty": "",
      "device_name": "Covid-19 Test Home Collection Kit Devices",
      "review_code": "",
      "unclassified_reason": "11",
      "medical_specialty_description": "Unknown",
      "device_class": "N",
      "definition": "Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "8"
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}