DevicePMAs@therightstef:N50510_S132 / 286-289 JSONTXT

Approval for the addition of the antibiotic chloramphenicol at concentrations of 2, 8 and 16 micrograms/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 chloramphenicol in the range of <=2 to >=32 micrograms/ml.

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PMA_MER 1 (1)