November 19, 2019

Rheonix Inc. Files 510(k) Seeking FDA Clearance of Triplex Sexually Transmitted Infection Assay

ITHACA, N.Y. — Rheonix, Inc. Rheonix filed its first 510(k) on November 4, seeking to gain FDA clearance of its Rheonix STI TriPlex™ Assay (a PCR-based assay for the simultaneous detection for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis) as well as the Rheonix Encompass MDx® Workstation, a fully automated “sample-to-answer” system capable of taking untreated clinical specimens and extracting, purifying and PCR amplifying DNA targets.  In addition the 510(k) filing… Read More »