Device Dossier

Multiple infectious organism IVDs

Device Dossier for Multiple infectious organism IVDs (CT923 - Multiple infectious organism IVDs, Class 3, sponsor Pale Blue Medical Trading). ARTG…

Intended purpose

Candida albicans/Trichomonas vaginalis/Gardnerella vaginalis antigen Combo Test Kit (LFIA) is a latex microsphere immunochromatography for the rapid qualitative detection of Candida albicans, Trichomonas vaginalis, and Gardnerella vaginalis in female vaginal swab samples in vitro. It is used to aid in the diagnosis of Candidiasis, Trichomoniasis, and Bacterial Vaginosis at the point of care by health professionals. The kit is to be used with Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA) External Quality Control Swab Kit to validate the correct performance of the test procedure.

TGA Public Summary