Intended Use; Test Principle - Fora Diamond PRIMA Owner's Manual

Intended Use

This system is intended for use outside the body (in vitro diagnostic
use) by people with diabetes at home and by health care professionals
in clinical settings as an aid to monitoring the effectiveness of diabetes
control. It is intended to be used for the quantitative measurement of
glucose (sugar) in samples of venous whole blood and fresh capillary
whole blood (from the finger, palm, forearm, upper arm, calf and thigh). It
should not be used for the diagnosis of diabetes, or testing on newborns.
Professionals may test with capillary and venous blood sample; home
use is limited to capillary whole blood testing. Use only heparin for
anticoagulation of whole blood.

Test Principle

Your system measures the amount of sugar (glucose) in whole blood.
The glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip. The
meter measures the current, calculates the blood glucose level, and
displays the result. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.
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