Bdprobetec Et Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified DNA Assay

• • Terminated Z-2658-2011 FDA Unclassified (pre-2012) ·initiated 29 Sep 2010 ·on shared 510(k) K984631

  In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.

• • Terminated Z-1094-03 FDA Unclassified (pre-2012) ·initiated 21 Jul 2003

  Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K984631 ↗

FDA Product Code

LSL

Device Class

Class II

Regulation

21 CFR Part 866.3390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Becton Dickinson Microbiology Systems →