The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood
The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of HbA1c/Total Hemoglobin ration and must not be used individually for diagnostic purposes
