|Trade Name||VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN|
|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 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.