FDAnews
www.fdanews.com/articles/62596-quidel-announces-fda-510-k-clearance-of-their-new-rapid-test-for-detection-of-respiratory-syncytial-virus-rsv

QUIDEL ANNOUNCES FDA 510(K) CLEARANCE OF THEIR NEW RAPID TEST FOR DETECTION OF RESPIRATORY SYNCYTIAL VIRUS (RSV)

September 18, 2006

Quidel Corporation, a leading provider of rapid point-of-care (POC) diagnostic tests, today launched their QuickVue RSV test upon receiving clearance from the FDA. The QuickVue RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab and nasopharyngeal aspirate specimens from symptomatic patients 18 years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute RSV viral infections. RSV infection is recognized as the leading cause of hospitalization of children during the first year of life.

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