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Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use

The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips. This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

Glucose Meter-Check Solution Roche ACCU-CHEK is intended to assess the performance of the following Roche ACCU-CHEK blood glucose monitoring systems: · Roche ACCU-CHEK Nano SmartView® using SmartView® test strips - · Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus® test strips - · Roche ACCU-CHEK Active® using ACCU-CHEK Active test strips - Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEK Compact test strips. - · Roche ACCU-CHEK Advantage using Comfort Curve® test strips Glucose Meter-Check Solution for Roche ACCU-CHEK is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

Glucose Meter-Check Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand BGM Systems listed in the package insert at recover glucose values within the interval recommended in ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for selftesting in managing diabetes mellitus for most meter types (Aviva, SmartView, Advantage), and comparable to solutions currently marketed by Roche for others (Active, Compact). This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. Glucose Meter-Check Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose and has been optimized to simulate the response of whole blood on the Roche ACCU-CHEK blood glucose monitoring systems. The solution contains no hazardous, human or animal derived components. The solution is recognized as a control automatically by the ACCU-CHEK Aviva and Nano SmartView meters to perform consistently as the Roche branded products.

Glucose Meter-Check Solution for Bayer is intended to assess the performance of the following Bayer blood glucose test systems: - Bayer Contour Next blood glucose monitoring systems - Bayer Breeze 2 blood glucose monitoring systems - Bayer Contour and Contour TS blood glucose monitoring systems Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

Glucose Meter-Check Control Solution is a viscosity-adjusted, aqueous liquid glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. Glucose Meter-Check Control Solution is intended for use to verify the performance of the Bayer BGM systems listed in the package insert and is intended for use by healthcare professionals and people with diabetes mellitus at home. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. Glucose Meter-Check Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

Glucose Meter-Check Solution for Infopia is intended for use to verify the performance and correct operation of Infopia blood glucose monitoring test systems utilizing Infopia glucose test strips. Glucose Meter-Check Solution for Infopia is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

Glucose Meter-Check Solution for Infopia is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Solution is formulated for optimal performance on Infopia glucose meters using Infopia test strips. This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range corresponding to Interval 2 of the glucose contration intervals for evalution of intermediate precision in ISO 151972 (96 to 144 mg/dL). This solution has been optimized to simulate the response of whole blood on the blood glucose test systems manufactured by Infopia using Infopia blood glucose test strips. The solution contains no hazardous, human or animal derived components.

Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.

Glucose Meter-Check Control Solution for NIPRO TRUEresult is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on NIPRO TRUEresult glucose meters. The product is provided in 2 levels, 1 representing hypoglycemia (low blood glucose) and 2, representing typical fasting blood glucose levels in non-diabetic persons.

The Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home.

Glucose Meter-Check Control Solution for AgaMatrix is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on AgaMatrix glucose meters utilizing the WaveSense family of test strips.

LifeScan OneTouch Ultra Control Solution is intended for use to verify the performance of the LifeScan OneTouch Ultra Family and the OneTouch Ping™ Meter Remote blood glucose monitoring test systems at a glucose level printed on the test strip vial. The LifeScan OneTouch Ultra Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. LifeScan OneTouch Select Control Solution is intended for use to verify the performance of the LifeScan OneTouch Select blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Select Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. LifeScan OneTouch Vita Control Solution is intended for use to verify the performance of the LifeScan OneTouch Vita blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Vita Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

The control solution is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The primary differences in the composition of the OneTouch Select, Ultra and Vita branded Control Solutions to that of the current, OneTouch Ultra Control are the type and relative content of buffer system, type and relative content of the viscosity adjusting agent, type and relative content of the preservative system, a lower concentration of dye, and a relative reduction in the content of water. The OneTouch Ultra control is currently in use with all LifeScan blood glucose test systems under the OneTouch Ultra, OneTouch Select and OneTouch Vita brands. The new control solution is reformulated for optimized performance across these various brands of test strips, and will be distributed under the same brands as the current Ultra control. This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range typically considered normal, fasting glucose for a non-diabetic person. This solution has been optimized to simulate the response of whole blood on the LifeScan OneTouch Ultra, Select and Vita branded blood glucose test systems. The solution contains no hazardous, human or animal derived components.

Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix InSure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.

Enterix InSure FIT FOBT Controls is a two-level, aqueous control solution. Enterix InSure FIT FOBT Controls is intended for use to verify the performance of Enterix InSure FIT product. The Enterix InSure FIT Test method is based on the detection of human hemoglobin (hHb). Human hemoglobin indicates the presence of blood in the stool. The test detects the globin (protein) portion of the hHb molecule. Because globin does not survive passage through the upper gastrointestinal (GI) tract, any globin in the stool indicates that there is bleeding in the lower colon or rectum, the region where colorectal cancers originate. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. Enterix InSure FIT FOBT Controls is a non-hazardous aqueous solution containing bovine albumin, salts, buffers preservatives and in addition contains human hemoglobin in the positive control.

OMNIS Health Embrace Glucose Control Solution is intended for in vitro diagnostic use to assess the performance of the OMNIS Health Embrace blood glucose test systems by healthcare professionals and in the home by people with diabetes mellitus.

OMNIS Health Embrace Glucose Control Solution is a two-level, viscosity-adjusted, aqueous liquid glucose control solution. OMNIS Health Embrace Glucose Control Solution is intended for use to verify the performance of OMNIS Health Embrace blood glucose test systems at glucose levels within the normal fasting blood glucose range for non-diabetic persons, and at elevated ranges consistent with hyperglycemia. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. OMNIS Health Embrace Glucose Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.

RNA Medical® Brand Glucose and ß-Ketone Calibration Verification Controls are assayed materials for confirming the calibration and linearity of glucose and ß-ketone at the upper and lower limits of the reportable range and at three (3) points within the range. This product is for use with the Precision Xceed Pro Blood Glucose and ß-ketone Monitoring System, which uses Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood B-Ketone Test Strips. It is not for use with the Precision PCx System or the i-STAT® 1 Analyzer, which use Precision PCx Test Strips, Precision PCx Plus Test Strips, or i-STAT 1 glucose cartridges. RNA Medical Glucose and ß-Ketone Calibration Verification Controls is intended for use by healthcare professionals. For In Vitro Diagnostic Use

RNA Medical Glucose and ß-Ketone Calibration Verification Controls is a five-level. viscosity-adjusted, aqueous liquid glucose and ß-ketone control linearity set optimized for use with the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and B-Ketone Monitoring System using Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood β-Ketone Test Strips. RNA Medical Glucose and β-Ketone Calibration Verification Controls provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. RNA Medical Glucose and β-Ketone Calibration Verification Controls contains glucose and ketone values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance of the blood glucose and blood ketone systems listed on the package insert. This material is comprised of an aqueous solution of glucose (0.03% - 0.40%), β-hydroxybutyrate (0.01% - 0.12%), and non-reactive ingredients (viscosity enhancing agent, dye, buffer, and preservative) prepared in five specific glucose and ketone concentrations. These controls contain no hazardous or human biological materials.