www.fdanews.com/articles/180625-bd-claims-influenza-detection-test-meets-fdas-new-performance-requirements
BD Claims Influenza Detection Test Meets FDA's New Performance Requirements
February 22, 2017
New Jersey–based BD (Becton, Dickinson and Company) says its BD Veritor system flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements introduced when the agency reclassified rapid flu tests from Class I to Class II.
The shift from Class I to Class II devices was prompted by the failure of some point-of-care flu tests during the 2009 pandemic. — Cynthia Jessup