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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.
 
Trade NameVITEK SYSTEMS "GENERAL SUSCEPTIBILITY CARD"
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
PMA NumberN50510
Supplement NumberS080
Date Received04/01/1998
Decision Date04/14/1998
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a limitation to use an alternative method to confirm results for the testing of pseudomonas aeruginosa with the antibiotic cefepime. The device, as modified, will be marketed under the trade name vitek gram negative susceptibility card in three concentrations (equivalent to 4, 8 and 16 ug/ml) and is indciated for the testing of rapidly growing aerobic and/or facultatively anaerobic gram negative bacilli.
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