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…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
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.