{
  "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
    }
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  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PET",
      "openfda": {
        "registration_number": [
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          "8021924",
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      "review_panel": "IM",
      "medical_specialty": "IM",
      "device_name": "Anti-Ss-A Ro60 Autoantibodies",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum.  The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.",
      "regulation_number": "866.5100",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
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}