7
Intended Use
The ReliOn® Prime Blood Glucose Monitoring System 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. It is not intended for the
diagnosis of or screening for Diabetes Mellitus, and is not intended for use on
neonates.
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