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For in vitro diagnostic use: System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation. This 510(k) application is for System U3/Gentamicin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 g/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

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