BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

• • Ongoing Z-0630-2022 FDA Class II ·initiated 5 Jan 2022

  May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.

• • Terminated Z-1313-2019 FDA Class II ·initiated 3 Apr 2019

  Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment

510(k) Number

K180438 ↗

FDA Product Code

PSZ

Device Class

Class II

Regulation

21 CFR Part 866.3328

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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