{
  "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": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NRX",
      "openfda": {},
      "review_panel": "IM",
      "medical_specialty": "IM",
      "device_name": "Complement 4d (C4d) And Complement Receptor 1 (Cr1)",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus.",
      "regulation_number": "866.5820",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}