DevicePMAs@therightstef:N50510_S138 / 359-383
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Approval for the addition of the antibiotic vancomycin at concentrations of 0.5 and 1 ug/ml to the vitek(r) 2 s. pneumoniae susceptibility test system. The device, as modified, will be marketed under the trade name vitek(r) 2 s. pneumoniae susceptibility test cards for use in the vitek(r) 2 system and is indicated for use for the susceptibility testing of streptococcus pneumoniae to vancomycin in the range of <=1 to >=2 micrograms/ml.
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