Arkray Glucocard 01 - Intended Use; The System Includes

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Intended Use
The GLUCOCARD™ 01 Blood Glucose Monitoring System meter
is intended for the quantitative measurement of glucose in fresh
capillary whole blood samples drawn from the fingertips 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