{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OMI",
      "openfda": {
        "k_number": [
          "K080008",
          "K120572"
        ],
        "registration_number": [
          "3032705",
          "2915274"
        ],
        "fei_number": [
          "2915274",
          "3002701146"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and  qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma.  Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.",
      "regulation_number": "866.3510",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}