BIONIME GM100 Blood Glucose Monitoring system
Accuracy:
95% of the measured glucose values shall fall within either,Glucose concentrations < 5.5mmol/L (100mg/dL),
difference within ± 0.83mmol/L (15mg/dL),Glucose concentrations ≥5.5mmol/L (100mg/dL), bias within ± 15%.
Precision:
Glucose concentrations < 5.5mmol/L (100mg/dL), SD < 0.28mmol/L (5mg/dL),Glucose concentrations ≥ 5.5mmol/L (100mg/dL), CV < 5%.
Fully comply with ISO 15197:2013 and FDA approval (For other received credentials, please contact us.)
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