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The KetoSens BT Blood ß-Ketone Monitoring System is intended for the quantitative measurement of 0-Ketone (betahydroxybutyrate) level in capillary whole blood drawn from the fingertip. The KetoSens BT Blood β-Ketone Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of ketoacidosis control. The system is not intended for use in the diagnosis of or screening for ketoacidosis and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared. The KetoSens Blood 0-Ketone Test Strips work with the KetoSens BT Blood 0-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the finger.

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VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01). The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the glucose and/or ß-ketone concentration respectively in fresh capillary whole blood samples drawn from the fingertips. The test principle of the ß-ketone is based on the amperometric detection of ß-hydroxybutyrate (also known as 3-hydroxybutyrate) in whole blood. β-hydroxybutyrate is converted by the enzyme ß-hydroxybutyrate dehydrogenase to acetoacetate. The magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample. VivaChek™ Blood Glucose and ß-Ketone Monitoring System (Model: VGM200) contains Bluetooth Low Energy (BLE), it complies with US federal quidelines, Part 15 of the FCC Rules for devices with RF capability.

KET-1 System: The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -ketone) in fresh capillary whole blood from fingertips. It should only be used by a single patient and it should not be shared. 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 monitoring the effectiveness of diabetes control programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal use. The KET-1 Blood Ketone Monitoring System is comprised of the KET-1 Blood Ketone Meter and KET-1 Blood Ketone Test Strip.

The KET-1 Blood Ketone Monitoring System consists of the KET-1 Blood Ketone Meter, KET-1 Blood Ketone Test Strips, and KET-1 Ketone Control Solutions (Level 1 and Level 2). The system is for self-testing of blood ketone. The KET-1 Blood Ketone Test Strips and KET-1 Ketone Control Solutions are purchased separately.

The TD-4140 Smart Dongle Blood Glucose plus [-ketone Monitoring System consists of the Smart Dongle blood glucose test strips, Smart Dongle {}-ketone test strips, and the Procheck mobile application as the display component of the system. This system is intended to be used for the quantitative measurement of glucose (sugar) and fketone in fresh capillary whole blood from the finger. This 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. It is intended to be used by a single person and should not be shared. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

The TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle 0-ketone test strips, and the Procheck mobile application as the display component of the system. This system is compatible to iPhone series, including iPhone 4/4s, 5/5s, 6/6 plus, and iPod touch 5. These products have been designed, tested, and proven to work together as a system to produce accurate test results. The Smart Dongle meter should only be used with the Smart Dongle Blood Glucose test strips and the Smart Dongle ß-ketone test strips.

KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood B-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared. The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip. KetoSens Multi Blood p-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for 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. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices. The KetoSens Multi Blood p-Ketone Test Strips work with Blood ß-Ketone Meter to quantitatively measure Blood B-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.

The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System consists of a meter, single use test strips, and control solutions with two different B-Ketone concentrations ("Control A" and "Control B" ranges). The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the Blood ß-Ketone level in whole blood samples using a small electrical current generated in the test strips.

The Healthy Me™ Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets. The Healthy Me™ Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes. The On Call Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets. The On Call Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes.

On Call® & Healthy Me" Ketone Reagent Strips for Urinalysis consists of a Plastic Strip to which a regent pad is affixed. The reagent pad reacts with the urine and provides a visible color reaction. On Call® & Healthy Me™ Ketone Reagent Strips for Urinalysis are packaged along with a drying agent in a Canister bottle. Each strip is stable and ready to use upon removal from the Canister. The entire reagent strip is disposable. Results are obtained by direct comparison to the test strip with a color blocks printed on the bottle label. Accurate timing is essential to provide optimal results. No calculations or laboratory instruments are needed.

The Precision Xtra / Optium Blood ß-Ketone Test Strips are intended to quantitatively measure blood ß-Ketone (Beta-Hydroxybutyrate) in fresh capillary whole blood from the fingertip. The test strips are for use outside the body (in vitro diagnostic use) and are for self-testing or healthcare professional use. Healthcare professionals may also use venous whole blood samples, provided the samples are used within 30 minutes of collection. The test strip is to be used for ketone concentrations in persons with diabetes and other conditions.

The Precision® Xtra™ Diabetes Monitoring System utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of ß-hydroxybutyrate (ß-ketone) present in the sample, providing a quantitative measure of ß-ketone in whole blood and control solutions.

The Neo Diagnostics KetoChecks is intended for the identification of ketones in urine and can be used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as Acetoacetic acid) and for monitoring patients on ketogenic diets and patients with diabetes. The test is indicated for use by professionals and for Over the Counter use by lay people.

KetoChecks for Urinalysis is firm plastic strips to which a reagent area is affixed. Depending on the product being used, KetoChecks provides a test for Ketone (Acetoacetic acid) in Urine. Test results may provide information regarding the status of carbohydrate metabolism. Please refer to the outside box and bottle label for the specific test parameters of the product you are using. KetoChecks is packaged along with a drying agent in a plastic bottle with a twist-off cap. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The directions must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Accurate timing is essential to provide optimal results. To obtain optimal results, it is necessary to use fresh, well-mixed, and uncentrifuged urine. No calculations or laboratory instruments are needed.