{
  "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": "2026-07-20",
    "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": "PJI",
      "openfda": {
        "k_number": [
          "K203035",
          "DEN140010"
        ],
        "registration_number": [
          "8043909"
        ],
        "fei_number": [
          "3002808498"
        ]
      },
      "review_panel": "IM",
      "medical_specialty": "IM",
      "device_name": "Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper.  It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).",
      "regulation_number": "866.5930",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}