FDAnews
www.fdanews.com/articles/178061-alere-receives-fda-clearance-for-alere-i-rsv-rapid-molecular-test

Alere Receives FDA Clearance for Alere I RSV Rapid Molecular Test

August 19, 2016

FDA grants 510 (k) marketing clearance for Alere’s molecular test that detects respiratory syncytial virus (RSV) in children and adults.

Alere i RSV is significantly faster than conventional polymerase chain reaction (PCR) tests delivering results in 13 minutes or less.

The molecular test will be available for use in hospitals in time for the 2016-2017 respiratory season. — Cynthia Jessup

View today's stories