Diazyme Laboratories, Inc. DIRECT HBA1C ASSAY
The Diazyme Direct HbA1c Assay (DZ168C-KY1) is an in vitro diagnostic reagent kit designed for the quantitative determination of hemoglobin A1c (HbA1c) in human whole blood using automated clinical chemistry analyzers. This assay utilizes a latex-enhanced immunoturbidimetric method, providing accurate and precise results for the monitoring and diagnosis of diabetes mellitus. The kit is intended for professional use in clinical laboratories and is compatible with a wide range of chemistry analyzers. The Direct HbA1c Assay offers a convenient workflow, requiring no sample pretreatment, and delivers results that are traceable to IFCC and NGSP reference methods.