{
  "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": "SFL",
      "openfda": {
        "pma_number": [
          "P250005",
          "P250046",
          "P240026"
        ],
        "registration_number": [
          "2134567",
          "3009972873"
        ],
        "fei_number": [
          "3002622561",
          "3009972873"
        ]
      },
      "review_panel": "PA",
      "medical_specialty": "",
      "device_name": "Nucleic Acid Based Assay, Microsatellite Instability",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "The microsatellite instability (MSI) companion diagnostic is nucleic acid based (molecular) in vitro diagnostic device intended for the qualitative detection of a panel of molecular biomarkers for identification of MSI in human clinical tissue specimens. It reports MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H). The MSI companion diagnostic is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess MSI status which may be associated with a better clinical response to specific FDA approved therapeutic drugs.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}