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Medical Devices / Submissions and Approvals

BD Claims Influenza Detection Test Meets FDA's New Performance Requirements

Feb. 23, 2017
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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

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