CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 2022–Rheonix announced that the FDA has granted 510(k) clearance for its automated Encompass MDx Workstation along with its STI TriPlex assay and Male Urine Collection Kit for the detection of sexually transmitted infections. The molecular testing device is a closed system that is automated from sample loading to result reporting, provides direct tube sampling, and contains all the reagents needed.
The Rheonix STI TriPlex assay is approved for simultaneous detection and differentiation of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The assay and collection device are approved for use in male urine samples.
Pages: 1 2