Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Roche Diagnostics). ARTG record,…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
Test strips designed to measure blood glucose in blood when used in combination with a dedicated blood glucose meter by people with diabetes or their health care professionals. The analytical quality of the blood glucose result is monitored through the use of purpose designed quality control solutions.