Device Dossier
Clinical chemistry biological screening IVDs
Device Dossier for Clinical chemistry biological screening IVDs (CT1236 - Clinical chemistry biological screening IVDs, Class 2, sponsor 2San). ARTG…
- GMDN category: CT1236 - Clinical chemistry biological screening IVDs
Intended purpose
Vaginal PH:The Vaginal pH Rapid Test Panel (Vaginal Swab) is a rapid dry chemical method for the semi-quantitative detection of pH in female vaginal swab specimens to aid in the diagnosis of bacterial vaginosis. UTI: The Urinary Tract Infections Test (Urine) compromises firm plastic strips onto which several separate reagents are affixed. The test is for the qualitative detection following analytes in urine: Leukocytes, Blood, Nitrite and Protein. The Urinary Tract Infections Test (Urine) is for single use in self-testing.