Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Emergo). ARTG record, intended purpose,…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
PreciS-A HbA1C Test Kit is intended to be used with the PreciS-A HbA1c Analyzer to quantitatively measure hemoglobin A1c (HbA1c) level in whole blood (capillary blood). This test kit is for professional use only, as an aid to monitor the effectiveness of diabetes control.