Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay

• • Terminated Z-1215-2013 FDA Class II ·initiated 8 Feb 2013 ·on shared 510(k) K090827

  Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

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

510(k) Number

K090827 ↗

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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