Device Dossier

Pty Ltd - Clinical chemistry biological screening IVDs

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

Intended purpose

The Urinary Tract Infections Rapid Test (Urine) is firm plastic strips onto which several separate reagent areas are affixed. The test is for the qualitative detection of the following analytes in human urine: Blood, Protein, Nitrite and Leukocytes. The Urinary Tract Infections Rapid Test (Urine) is for single use in self-testing.

TGA Public Summary