Ortho Clinical Diagnostics Announces FDA Approval of VITROS Chemistry Products HbA1c Reagent Kit for Diagnosis of Diabetes
Wednesday, June 24, 2015
Ortho Clinical Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the VITROS® Chemistry Products HbA1c Reagent Kit to be used on the VITROS® 5600 Integrated System, VITROS® 4600 Chemistry System, and the VITROS® 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in the diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.