Device Dossier

Chlamydia IVDs

Device Dossier for Chlamydia IVDs (CT782 - Chlamydia IVDs, Class 3, sponsor Ortho-Clinical Diagnostics). ARTG record, intended purpose, GMDN category —…

Intended purpose

The QuickVue Chlamydia test is a lateral flow immunoassay intended for the rapid, qualitative detection of Chlamydia directly from endocervical swab and cytology brush specimens. The test is intended for use as an aid in the presumptive diagnosis of chlamydial infection.

TGA Public Summary