Device Dossier

Clinical chemistry substrate IVDs

Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Point Of Care Diagnostics). ARTG…

Intended purpose

Blood glucose monitoring system/test strips to be used for the quantitative measurement of glucose (sugar) in fresh capillary, venous, arterial, and neonatal whole blood samples. Fresh capillary samples may be drawn from the fingertip, palm and forearm, and in the case of neonates, the heel.

TGA Public Summary