The Wellion GALILEO Compact Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshly collected capillary blood samples from the fingertips, forearm or palm. Testing is done outside the body (in vitro diagnostic use). It is intended both for self-testing by people with diabetes and for professional use by health workers in a clinical environment, as an aid in monitoring diabetes mellitus. Not intended for diagnosis or use in neonates.
The Wellion glucose test strip is intended for measuring the sugar level in capillary whole blood taken from the fingertip, palm or forearm with the Wellion GALILEO measuring device. This glucose test strip is calibrated to blood plasma for better comparison of results with laboratory results. It is intended for self-monitoring by patients who suffer from diabetes and health professionals or doctors. It is not intended for the diagnosis or screening of diabetes or the determination of glucose in newborns.
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