Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Share Info). ARTG record, intended…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
The AQ pro series blood glucose monitoring system is intended for use in the quantitative measurement of glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous). It is intended to be used by people with diabetes at home or clinical site as an aid in monitoring the effectiveness of their diabetes control programs. The blood glucose monitoring system is for in vitro diagnostic use only. It is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates. The AQ pro I blood glucose test strip is used with the AQ pro I blood glucose meter in the quantitative measurement of glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous). The AQ pro II blood glucose test strip is used with the AQ pro II blood glucose meter in the quantitative measurement of glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous). The AQ pro III blood glucose test strip is used with the AQ pro III blood glucose meter in the quantitative measurement of glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous). The Sinocare blood glucose control solution is used with the AQ pro series blood glucose meter and blood glucose test strip to check that the meter and test strip are working together properly. A control test also helps you practice proper testing technique.