7
Intended Use
This system is intended for use outside the body (
in vitro
diagnostic
use) by 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 fresh capillary, venous,
arterial, and neonatal whole blood samples. It should not be used for the
diagnosis of diabetes, or screening for diabetes mellitus.
Capillary samples may be drawn from the fingertip, and in the case of
neonates, from the heel.
The system is only used with single-use, auto-disabling lancing devices. It
can only be used with
FORA COMFORT pro GD40
test strips and
FORA
control solutions.
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.
Summary of Contents for COMFORT pro GD40
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