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The Glucose Hexokinase reagent set is intended to be used in a diagnostic laboratory setting by qualified laboratory technologists for the quantitative determination of glucose in human serum and plasma on the Pointe 360 Analyzer. It is for In Vitro diagnostic use only. The determination of glucose in serum and plasma is for use in the diagnosis and treatment of diabetes mellitus.

The Pointe 360 is a computerized bench top laboratory instrument. It is capable of automating all stages of assay processing that involve incubation, reagent delivery, mixing, optical reading, calculating, data storage and reporting within specified limits. The glucose reagent set for the Pointe 360 is an assay for the determination of glucose in plasma or serum.

This product is to be used for the quantitative determination of carbon dioxide in human serum by spectrophotometric analysis. The determination of the level of carbon dioxide in serum is commonly performed as an indicator of acid-base balance disturbances.

Carbon Dioxide Liquid Stable Reagent

The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.

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The Pointe Scientific, Inc. Ammonia / alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

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These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.

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This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are offen used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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This product is to be used in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.

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This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

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This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.

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