Treponema Pallidium assay receives FDA 510(k) approval for syphilis diagnostics- Roche
Roche has received 510(k) clearance from the FDA for a fully automated assay for the detection of antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the cobas e 411, cobas e 601, cobas e 602 and MODULARANALYTICS E170 analyzers. The Treponema pallidum assay is intended as an aid in the diagnosis of syphilis infection. The Roche Syphilis treponemal antibody test offers several advantages, including a specific screening test that provides an objective result, high throughput on an automated analyzer, and high specificity.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.