Device Dossier

Clinical chemistry biological screening IVDs

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

Intended purpose

The Urinary Tract Infections Test (Urine) test is for the qualitative detection of the Blood, Protein, Nitrite and Leukocytes in human urine. The Vaginal pH Rapid Test Panel (Vaginal Swab) is for the semi-quantitative detection of pH in female vaginal swab specimens to aid in the diagnosis of bacterial vaginosis. For self-testing in vitro diagnostic use only.

TGA Public Summary