Arkray Glucocard X-Meter - Intended Use of the GLUCOCARD X-METER

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Intended Use
The GLUCOCARD™ X-METER is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn
from the fingertips, forearm, upper arm, or palm. Testing is done
outside the body (In Vitro diagnostic use). It is indicated for use at
home (over the counter [OTC]) by persons with diabetes, or in clinical
settings by healthcare professionals, as an aid to monitor the
effectiveness of diabetes control.
The System Includes:
•Meter
•CarryingCase
•UserInstructionManual
•QuickReferenceGuide
•Self-testingLogbook
•MayalsoincludeTestStrips,Control
Solution, and Lancing Device and/or
Lancets
Carrying Case
Control Solution