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The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly). The Medisign GH82 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly). The Medisign GH83 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly). The Medisign GH81 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly). The Medisign GH82 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly). The Medisign GH83 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).

The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, and GH83 BT Blood Glucose Monitoring System quantitatively measures the glucose in the whole blood sample by using a harmless electrical current produced by a chemical reaction between the glucose in the blood and Flavin adenine dinucleotide-Glucose dehydrogenase (FAD-GDH) on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements from this system are reported as plasma equivalents. The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring Systems are for over-the-counter use and systems' kit basically consist of a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, a carrying case, however some kits may not have test strips or a lancing device or sterile lancets. The Medisign GH81. GH82. GH83 Blood Glucose Monitoring System allows to transmit blood glucose test results to a PC via an external USB cable and Medisign GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring System can transmit blood glucose test results to a PC via an external USB cable or a Bluetooth Low Energy transmitter in meter. The Medisign GH81 Blood Glucose Test Strip is for the Medisign GH81 and GH81 BT Blood Glucose Meter. The Medisign GH82 Blood Glucose Test Strip is for the Medisign GH82 and GH82 BT Blood Glucose Meter. The Medisign GH83 Blood Glucose Test Strip is for the Medisign GH83 and GH83 BT Blood Glucose Meter. Each of test strip box may contain 10 test strips or 25 test strips or 50 test strips with one vial or 50 test strips split into two vials. Also, test strip box may contain 25 or 50 test strips packed separately for each test strip. The Medisign Link Diabetes Management Software is an optional software accessory and were previously cleared in k133260.