Device typeGlucose monitoring system IVD, point-of-care: A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
FDA categoryPrescription Use Blood Glucose Meter For Near-Patient Testing
Device ID00015482600501
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information