|Trade Name||VITEK 2 SYSTEM|
|Classification Name||susceptibility test cards, antimicrobial|
|Generic Name||antimicrobial susceptibility test system-short incubation|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for software revisions for major modifications to the design of the device in order to automate manual operations and enhance performance. The device as modified will be marketed under the trade name vitek(r) 2 system and is intended as a laboratory aid in the determination of the in vitro susceptibility of bacteria when tested on a gram negative susceptibility test card or a gram positive susceptibility test card containing antimicrobial agents at selected concentrations.