Diazyme Gets FDA 510(k) Clearance to Market Direct HbA1c Assay

By |February 13th, 2017|Direct HbA1c Assay|0 Comments

Diazyme Laboratories recently announced that they received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Direct HbA1c assay (Enzymatic, On-Board Lysis). This new enzymatic Direct HbA1c assay is the most convenient and accurate HbA1c assay method available for use on general clinical chemistry analyzers. Measurement of hemoglobin A1c is a [...]