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It is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), and diagnosis (aid in diagnosis) of diabetes.

The specific disorder is covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, plasma, whole blood and hemolysate, 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" } ] } } ] }