Main > ENDOCRINOLOGY > Diabetes. Diagnostics. > Glycated Hemoglobin in Blood (**) > Co.: USA. Gd. USA>Approved > Description
Co. announced today that the U.S. Food and Drug Administration (FDA) has granted Co. 510(k) clearance to market its Direct Enzymatic Hemoglobin A1c (HbA1c) Assay Kit for the quantitative determination of HbA1c in human whole blood samples.
The company also announced today that it has successfully completed the National Glycohemoglobin Standardization Program (NGSP; www.ngsp.org) manufacturer certification for this assay. The Co. Direct Enzymatic HbA1c method is now traceable to the Diabetes Control and Complications Trial (DCCT) reference method.
HbA1c is an important test recommended by the American Diabetic Association (ADA) for monitoring patient glycemic status. HbA1c refers to glucose modified hemoglobin A (HbA) specifically at N-terminal valine residues of hemoglobin beta chains.
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