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The Precision Xtra Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra System is for home (lay user) or professional use. The Precision Xtra System may also be used for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

The Precision™ Xtra™ Advanced Diabetes Management System for Blood Glucose and Ketone Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose (or Beta-Hydroxybutyrate ketone) present in the sample, providing a quantitative measure of glucose (or ketone) in whole blood and control solutions.

The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision. G Plus Point of Care Management System is for home (lay user) or professional use. The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.

The Precision·G Plus Point of Care Management System for Blood Glucose Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample providing a quantitative measure of glucose in whole blood and control solutions.

The Precision A1c Home HbA1c Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbA1c (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus. The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

The Precision A1c Home HbA1c Sample Collection Kit contains the materials necessary to collect a capillary blood sample from a finger-stick to a piece of filter paper and mail it to a clinical laboratory for the determination of percent hemoglobin A1c (also known as glycohemoglobin or glycosylated hemoglobin). The Precision A1c sample collection kit contains a lancet, patient information sheet, instruction sheet, alcohol pad, gauze pad, bandage, pre-paid mailing envelope, and a blood sample collection card (inside a zip-locked foil pouch containing a desiccant).

The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors. The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonate whole blood, provided the sample is used within 30 minutes of collection. The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole capillary blood. The Precision G Blood Glucose Testing System is intended for home or professional use.

The Precision QID and Precision G Blood Glucose Test Strips are identical in test strip design. Both test strips utilize amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. The Precision QID Blood Glucose Test Strips are for use with the Precision QID Blood Glucose Testing System and are also compatible with the MediSense 2 Card and Pen Blood Glucose Testing Systems. The Precision G Blood Glucose Test Strip is only for use with the Precision G Blood Glucose Testing System.

The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole blood. The Precision G Blood Glucose Testing System is intended for home or professional use. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.

The Precision G Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. A drop of whole blood or control solution is applied to the target area of the test strip and the assay is automatically initiated. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the Precision G Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 20 seconds.

The Precision QID Blood Glucose Test Strips are intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.

The Precision QID Blood Glucose Test Strip utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. Insertion of a test strip into the sensor, automatically turns the sensor on. A drop of whole blood or control solution is applied to the target area of the test strip and the assay is automatically initiated. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the Precision QID Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 20 seconds.

The ExacTech RSG Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The product is designed for home or professional use.

The ExacTech RSG Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. After inserting a test strip into the sensor, a drop of whole blood or control solution is applied to the target area of the test strip and the sensor button is pressed. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the ExacTech RSG Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 30 seconds.