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The Tyson Bio HS100 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HS100 Blood Glucose Monitoring System is comprised of the Tyson Bio HS100 Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip. The Tyson Bio HS100-B 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HS100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HS100-B Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.

The Tyson Bio HS100 Blood Glucose Monitoring System consists of three main components: the meter, test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as k170079) and Tyson Bio 50H Control Solution (Control Solutions are the same as k170079) can be used with the Tyson Bio HS100 Blood Glucose Monitoring System. The Tyson Bio HS100-B Blood Glucose Monitoring System consists of three main components: the meter (with Bluetooth feature), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as k170079) and Tyson Bio 50H Control Solutions (Control Solutions are the same as k170079) can be used with the Tyson Bio HS100-B Blood Glucose Monitoring System. The Tyson Bio HS100 / HS100-B Blood Glucose Monitoring System consists of: - Tyson Bio HS100 / HS100-B Blood Glucose Meter - Tyson Bio 50H Blood Glucose Test Strips (Test Strips are the same as k170079)

The Tyson Bio HT100-A 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HT100-A Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-A Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip. The Tyson Bio HT100-C 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HT100-C Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-C Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.

The Tyson Bio HT100-A Blood Glucose Monitoring System (with Voice feature) consists of three main components: the meter (with built-in Voice feature), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as k170079) and Tyson Bio 50H Control Solution (Control Solutions are the same as k170079) can be used with the Tyson Bio HT100-A Blood Glucose Monitoring System. The Tyson Bio HT100-C Blood Glucose Monitoring System (with Voice and Bluetooth features) consists of three main components: the meter (with built-in Voice and Bluetooth features), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as k170079) and Tyson Bio 50H Control Solutions (Control Solutions are the same as k170079) can be used with the Tyson Bio HT100-C Blood Glucose Monitoring System. The Tyson Bio HT100-A / HT100-C Blood Glucose Monitoring System consists of: - a. Tyson Bio HT100-A / HT100-C Blood Glucose Meter - Tyson Bio 50H Test Strips b. (Test Strips are the same as k170079)

The Tyson Bio HT100 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HT100 Blood Glucose Monitoring System is comprised of the Tyson Bio HT100 Blood Glucose Meter and Tyson Bio HT100 Blood Glucose Test Strip. The Tyson Bio HT100-B 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HT100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-B Blood Glucose Meter and Tyson Bio HT100-B Blood Glucose Test Strip.

The Tyson Bio HT100 Blood Glucose Monitoring System consists of three main components: the meter, test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only Tyson Bio HT100 Test Strips and Tyson Bio HT100 Control Solution with the Tyson Bio HT100 Blood Glucose Monitoring System. The Tyson Bio HT100-B Blood Glucose Monitoring System (with Bluetooth feature) consists of three main components: the meter (with built-in Bluetooth), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only Tyson Bio HT100-B Test Strips and Tyson Bio HT100-B Control Solution with the Tyson Bio HT100-B Blood Glucose Monitoring System. The Tyson Bio HT100 / HT100-B Blood Glucose Monitoring System consists of: - Tyson Bio HT100 / HT100-B Blood Glucose Meter - Tyson Bio HT100 / HT100-B Test Strips

The TysonBio AC500 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC500 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC500 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 TysonBio AC500 Test Strips are for use with the TysonBio AC500 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results. The TysonBio AC800 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC800 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC800 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC800 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 TysonBio AC800 contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC800 Test Strips are for use with the TysonBio AC800 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results. The TysonBio AC500 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC500 Pro 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 single-use, auto-disabling lancing devices. The TysonBio AC500 Pro 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 TysonBio AC500 Pro Blood Glucose Test Strips are for use with the TysonBio AC500 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm, The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results. The TysonBio AC800 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC800 Pro 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 single-use, auto-disabling lancing devices. The TysonBio AC800 Pro 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 TysonBio AC800 Pro contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC800 Pro Blood Glucose Test Strips are for use with the TysonBio AC800 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio AC500/AC800 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio AC500/AC800 Test Strips and TysonBio AC500/AC800 Control Solution with the TysonBio AC500/AC800 Blood Glucose Monitoring System. The TysonBio AC500 Pro/AC800 Pro Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio AC500 Pro/AC800 Pro Test Strips and TysonBio AC500/AC800 Control Solution with the TysonBio AC500 Pro/AC800 Pro Blood Glucose Monitoring System. The TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Monitoring System consists of: a. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Meter b. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Test Strips c. TysonBio AC500/AC800 Control Solution

The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio MD100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio MD100 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 TysonBio MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure qlucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results. The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro 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 TysonBio MD100 Pro 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 TysonBio MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio MD100 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Blood Glucose Monitoring System. The TysonBio MD100 Pro Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Pro Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Pro Blood Glucose Monitoring System. The TysonBio MD100 / MD100 Pro Blood Glucose Monitoring System consists of: a. TysonBio MD100/MD100 Pro Blood Glucose Meter b. TysonBio MD100/MD100 Pro Test Strips TysonBio MD100 Control Solution

The TysonBio AC100 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC100 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 TysonBio AC100 contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC100 Test Strips are for use with the TysonBio AC100 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC100 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC100 Pro 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 single-use lancing devices. The TysonBio AC100 Pro 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 TysonBio AC100 Pro contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC100 Pro Blood Glucose Test Strips are for use with the TysonBio AC100 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC200 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 TysonBio AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC200 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC200 Pro 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 single-use lancing devices. The TysonBio AC200 Pro 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 TysonBio AC200 Pro Blood Glucose Test Strips are for use with the TysonBio AC200 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System is an amperometric biosensor, It is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System consist of three main products: the meter, Test Strips and Control Solutions. Use only TysonBio AC100/AC100 Pro Test Strips for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Test Strips for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems, and use i TysonBio AC100/AC100 Pro Control Solutions for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Control Solutions for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems to perform quality checks.

The Easy Step / DIACHEX PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro . diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. Easy Step / DIACHEX* PRO provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes. The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 5 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.

The TysonBio Link Health Management System is an optional software accessory for use with the following models with data management capabilities: a) EZ Smart-608 series meter, b) DIACHEX Series Blood Glucose Meter, and c) DIACHEX+ Series Blood Glucose Meter. When used with one of these meters, TysonBio Link Health Management System transfers data from the device's memory into a computer for enhanced data management. TysonBio Link Health Management System is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

The TysonBio Health Management System software is an optional software accessory for use with TysonBio blood glucose monitors with data management capabilities. When use with one of these meters, TysonBio Link Health Management System software transfers data from the devices records into a computer for enhanced data management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

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The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX DETERMINE / DIACHEX INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. DIACHEX* DETERMINE / DIACHEX* INFINITY provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes. The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.