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The DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or screening for diabetes, or testing on neonates. The DIAVUE Blood Glucose Test Strips are to be used with the DIAVUE Prudential Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. The DIAVUE Control Solutions are used with the DIAVUE Prudential Blood Glucose Meter and DIAVUE Blood Glucose Test Sreips to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.

The DIAVUE Prudential Blood Glucose Monitoring System consists of glucose meter, quick start user guide, user manual, warranty card, and carrying bag. Test strips, control solutions or sterile lancets can be purchased separately. DIAVUE Control Solution contains a known amount of glucose that reacts with test strips made by BioCare. Three levels of control solutions are available : level 1.level 2 and level 3.Operation of the control solution test is similar to blood glucose test except that you use DIAVUE control solution instead of a drop of blood. The control solutions should provide results within an expected range printed on the test strip vial label.