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System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System
The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS. Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)
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