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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 2 GRAM NEGATIVE AST FOR GENTAMICIN
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS104
Date Received08/20/1999
Decision Date01/06/2000
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the antibiotic gentamicin at concentrations of 4, 16, and 32 ug/ml to the viteck 2 gram negative 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 negative susceptibility test cards for the susceptibility testing of gram negative isolates to gentamicin in the range of <=1 to >=16 ug/ml.
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