Roche's (RHHBY) Treponema Pallidum Assay Receives FDA 510(k) Clearance
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Roche receives 510(k) clearance from FDA for Treponema pallidum assay to aid clinicians in the diagnosis of syphilis infection
September 26, 2016 11:56 AM EDTINDIANAPOLIS, Sept. 26, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (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 MODULAR ANALYTICS E170 analyzers.
The Treponema pallidum assay is intended as an aid in the diagnosis of syphilis infection. The Roche Syphilis... More
