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The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The BLE Smart Blood Glucose Test Strips are for use with the BLE Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly. The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.

BLE Smart Blood Glucose Monitoring System / BLE Smart Professional Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

The GDH Professional LED Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh, and venous whole blood. The GDH Professional LED Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional LED Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GDH Professional test strips are for use with the GDH Professional LED meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The GDH Professional control solutions are for use with the GDH Professional LED meter and GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly. The GDH Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and venous whole blood. The GDH Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GDH Professional test strips are for use with the GDH Professional meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The GDH Professional control solutions are for use with the GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are in vitro diagnostic devices designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.