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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (e.g., whole blood) to determine the level of glycated hemoglobin, a result of an irreversible nonenzymatic addition of glucose residues to hemoglobin. The level of glycated hemoglobin in blood is a measure of the integrated values for glucose over a period of several weeks, free from daily fluctuations of glucose level, providing additional information about glucose control. Glycated hemoglobin tests are not used for the general diagnosis of diabetes mellitus. Liquid chromatography methods are more widely used for determination of glycated hemoglobin than immunoassays.
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