FDA-cleared RPR test system, 5/16

May 2016—Gold Standard Diagnostics announced FDA 510(k) clearance of its AIX1000 Rapid Plasma Reagin Automated Test System for syphilis testing. The AIX1000 system fully automates the RPR test procedure from sample loading to result interpretation for titers and screens. Digital images of each result are retrievable on demand, for review anytime. Results interpretation is completed by a pattern-recognition algorithm that is objective and consistent.

Gold Standard Diagnostics, 855-268-6940