Diazyme Laboratories, Inc. DIRECT HBA1C ASSAY (Enzymatic, On-Board Lysis) (liquid stable
The Diazyme DIRECT HbA1c Assay (Enzymatic, On-Board Lysis) is a liquid stable, two-reagent system designed for the quantitative determination of hemoglobin A1c (HbA1c) in human whole blood using automated clinical chemistry analyzers. This assay utilizes an enzymatic method with on-board lysis, eliminating the need for manual sample preparation and providing accurate, precise results. The assay is traceable to the IFCC reference method and is intended for use in the diagnosis and monitoring of diabetes mellitus. The liquid stable format ensures ease of use and consistent performance.