FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß Ketone Monitoring Systems - K161738 on Nov-10-2016
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FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal whole blood, and for the quantitative measurement of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes. FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood β-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Meter to quantitatively measure β-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood. β-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 pro Blood Glucose and β-Ketone Monitoring System as a quality control check to verify the accuracy of blood ketone test results.

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2017
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