Device Dossier

Treponema (syphilis) IVDs

Device Dossier for Treponema (syphilis) IVDs (CT799 - Treponema (syphilis) IVDs, Class 3, sponsor Beckman Coulter). ARTG record, intended purpose, GMDN…

Intended purpose

Syphilis TP Latex assay is an in vitro diagnostic test used for the determination on AU Systems of the anti-Treponema pallidum (TP)antibody in serum and Li-heparin, EDTA or sodium citrate plasma.

TGA Public Summary