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BD Gets FDA OK, CLIA Waiver for Flu Test

NEW YORK (GenomeWeb News) – Becton Dickinson today said that it has received both US Food and Drug Administration clearance and a CLIA waiver for its new BD Veritor System for rapid detection of Flu A+B.

According to the company, BD Veritor is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver.

The system reports performance measured against polymerase chain reaction results. It incorporates BD's Nano Detection Particle and Adaptive Read Technology, requires little sample preparation time, and can run the test in 10 minutes.

"The new BD Veritor System provides a new approach for CLIA-waived rapid tests for influenza A+B by offering a combination of speed, accuracy, and convenience with an objective read that physicians can trust," Tom Polen , president of BD Diagnostics – Diagnostic Systems, said in a statement.