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It is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), diagnosis (aid in diagnosis) and prognosis; additionally, the device can be used to run companion diagnostic tests.
The specific disorder and testing populations are covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, urine, cerebrospinal fluid, oral fluid, hemolysate and plasma that are used for detecting and/or measuring analytes covered by the specific assays. The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only).",
"Country": "XR",
"Code": "Intended Use",
"Name": "Intended Use"
}
]
}
}
]
}
