Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
Roche Diagnostics Asia Pacific Pte Ltd
Class B IVD
Roche Diagnostics GmbH
Clinical chemistry
In vitro test for the quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in whole blood or hemolysate on Roche/Hitachi cobas c systems. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus. Moreover, this test is to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes.
Device System Info:[Device with measuring function]; Models: A1CDX3 Tina-quant Hemoglobin A1cDx Gen.3 - 07559674190, Cfas HbA1c Calibrator for automated systems - 04528417190, PreciControl HbA1c norm - 05479207190, PreciControl HbA1c path - 05912504190, Hemolyzing Reagent - 11488457122, A1CD Hemolyzing reagent - 07224648190, cobas c 513 analyzer - 07649142001, cobas c 513 analyzer - Software version 02-02 - 08161658001, cobas c 513 analyzer - Software version 02-03 - 08387222001, cobas c 513 analyzer - Software version 02-04 - 08778647001, cobas c 513 analyzer - Software version 02-05 - 09440194001
2018-01-17