Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Radiometer). ARTG record, intended…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
The HemoCue HbA1c 501 System is a point of care device which provides a convenient method for measuring the percentage of haemoglobin A1c (HbA1c%) in both capillary and anticoagulated venous whole blood samples. The HemoCue HbA1c 501 system is intended to be used by professionals in laboratories, clinics and hospitals.