Device typeGlucose monitoring system IVD, home-use: A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
FDA categorySystem, Test, Blood Glucose, Over The Counter
Device ID00891237001652
Catalog number1652
AvailabilityOver the counter
MRI safetyLabeling does not contain MRI Safety Information