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

By |February 13th, 2017|Direct HbA1c Assay|Comments Off on Diazyme Gets FDA 510(k) Clearance to Market Direct HbA1c Assay

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 [...]