|Trade Name||VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN|
|Classification Name||susceptibility test cards, antimicrobial|
|Generic Name||antimicrobial susceptibility test system-short incubation|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the antibiotic levofloxacin at concentrations of 0. 25, 2 and 8ug/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 test cards for the susceptibility testing of gram positive organism to levofloxacin in the range of <=. 125 to >= 8ug/ml.