www.fdanews.com/articles/174389-fda-grants-510k-clearance-to-cepheid-for-xpert-flursv-test
FDA Grants 510(k) Clearance to Cepheid for Xpert Flu+RSV Test
December 8, 2015
The FDA has awarded Cepheid 510(k) clearance and Clinical Laboratory Improvement Amendments waiver for its Xpert Flu+RSV Xpress test for use on the GeneXpert Xpress System.
The GeneXpert Xpress System is the first in a series of reference-quality molecular tests that Cepheid plans to deliver over the next several years.
The Xpert Flu+RSV Xpress test features high-level multiplexing, redundant target segments and extended coverage for human and avian influenza strain, according to Cepheid's Chief Medical and Technology Officer David Persing. — Michael Cipriano