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The BGM009 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and BGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The BGM009 Plus blood glucose monitoring system consists of the BGM009 Plus meter and BGM009 Test Strips. It is used for testing of blood glucose by self-testers at home.

MEG-2B Blood Glucose Monitoring System: The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). This system is indicated for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The MEG-2B Blood Glucose Monitoring System consists of the MEG-2B meter and MEG-2B Test Strips. It is used for testing of blood glucose by self-testers at home. The MEG-2B Pro Blood Glucose Monitoring System consists of the MEG-2B Pro meter and MEG-2B Pro Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The MEG-2B and MEG-2B Pro systems are identical other than trade names and details of product labeling.

The AutoSure Voice 3 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Plus Blood Glucose Test Strips are to be used with the AutoSure Voice 3 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

The AutoSure Voice 3 Plus blood glucose meter and AutoSure Plus test strips are used for testing of blood glucose by self-testers at home. Contrex Plus III Glucose Control Solutions are used for quality control testing of the system.

The purpose of the control solution test is to validate the performance of the GlucoSure STAR & GlucoTRACK Blood Glucose Monitoring Systems using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Control solution containing D-glucose as its reactive component for use as a quality control material for blood glucose monitoring systems.