DevicePMAs@therightstef:N50510_S110 JSONTXT 11 Projects

Approval is for the addition of the antibiotic norfloxacin at concentrations of 0.5, 1 and 4ug/ml to the Vitek 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Positive Susceptibility Cards for the susceptibility testing of gram positive organism to norfloxacin in the range of <= 0.25 to >=16ug/ml.