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ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis of diabetes, or for the testing of neonates. The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code* BMB-EA001S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. The meter also included speaking functions but has not been validated for use by the visually impaired. The ADVOCATE® Redi-Code* control solutions are for use with the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System consists of the ADVOCATE® Redi-Code BMB-EA004S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips, ADVOCATE® Redi-Code control solutions, lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.