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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
PMA NumberN50510
Supplement NumberS143
Date Received12/18/2000
Decision Date06/13/2001
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the antibiotic gatifloxacin at concentrations of 1, 4, and 8 mcg/ml to the vitek. Gram positive susceptibility panel. The device will be marketed under the trade name vitek. Gram positive susceptibility (gps) card for gatifloxacin, and is indicated for use in vitek. Gram positive susceptibility test cards for the susceptibility testing of staphylococcus aureus and staphylococcus saprophyticus isolates to gatifloxacin in the range of <=0. 5 to >=8 mcg/ml.