Device Dossier

Clinical chemistry biological screening IVDs

Device Dossier for Clinical chemistry biological screening IVDs (CT1236 - Clinical chemistry biological screening IVDs, Class 2, sponsor Roche…

Intended purpose

Test strips for the semiquantitative determination of specific gravity, pH, leucocytes, blood, haemoglobin, nitrites, ketones, bilirubin, urobilinogen, protein, glucose, albumin in urine samples. These test strips are intended for professional use and results may be visually obtained or may require specialised instrumentation.

TGA Public Summary