Bd Phoenix Automated Microbiology System-Minocycline (Gp) 1-32 Ug/Ml

• • Ongoing Z-0232-2023 FDA Class II ·initiated 13 Oct 2022

  Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic

• • Terminated Z-0570-2013 FDA Class II ·initiated 6 Nov 2012

  An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.

510(k) Number

K070809 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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