Clinical chemistry substrate IVDs

Intended purpose

The BGMS s intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh.It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The BGMS is not be used for the diagnosis of or screening for diabetes, nor for neonatal use.