|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM|
|Classification Name||susceptibility test cards, antimicrobial|
|Generic Name||antimicrobial susceptibility test system-short incubation|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The device, as modified, will be marketed under the trade name vitek 2 gram negative susceptibility test cards. Approval for the addition of the antibiotic imipenem at concentrations of 2, 4 and 16 micrograms/ml to the vitek 2 gram negative susceptibility test system.