BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today that it received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) Waiver from the U.S. Food and Drug Administration (FDA) for the BD Veritor™ System for Rapid Detection of Group A Strep . This is the first commercially available rapid Group A Strep test system that incorporates a digital result to receive CLIA Waiver. The new assay is cleared for use in hospitals, outpatient clinics and other patient-care settings.
Group A Strep is the most common bacterial cause of pharyngitis. More accurately determining the etiology of pharyngitis can help providers make more appropriate antibiotic treatment decisions.