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 SZ101 Blood Glucose Meter is intended to be used with SZ101 blood glucose test strip for quantitative measurement of glucose in human whole blood from the fingertip (capillary) or from the vein (venous). The SE101 Blood Glucose Meter is intended to be used with SE101 blood glucose test strip for quantitative measurement of glucose in human whole blood from the fingertip (capillary) or from the vein (venous). It is intended to be used by lay person for self-testing or to be used for near-patient testing as an aid for monitoring the effectiveness of diabetes control.