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Clinical chemistry reagents intended to be used in the performance of qualitative and/or quantitative chemical analyses of body fluids (typically human whole blood samples) to determine the level of HbA1c (glycated hemoglobin) with no significant interference from other hemoglobin (abnormal) variants such as HbC, HbS, HbE, or labile HbA1c. The level of glycated hemoglobin in blood is a measure of the integrated values for glucose over a period of two to three months, the level is free from daily fluctuations of glucose, and provides additional criteria for glucose control.
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