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For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus, Streptococcus, Gonococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This Etest 510(k) application is for MIC determination of Cefditoren in the range of 0.002 - 32 µg/ml with S. pneumoniae (penicillin susceptible strains only) and H. influenzae.

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This document is a 510(k) clearance letter from the FDA for a device called "Etest® Cefditoren." It does not contain information about acceptance criteria, device performance, or details of a study as requested. The content only confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

Therefore, I cannot provide the requested information based solely on the provided text. The document is essentially a regulatory approval notice, not a study report.

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