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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.
 
DeviceVITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
Applicant
BIOMERIEUX VITEK, INC.
595 anglum dr.
hazelwood, MO 63042-2395
PMA NumberN50510
Supplement NumberS110
Date Received08/25/1999
Decision Date01/31/2000
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for the addition of the antibiotic norfloxacin at concentrations of 0. 5, 1 and 4ug/ml to the vitek 2 gram positive 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 positive susceptibility cards for the susceptibility testing of gram positive organism to norfloxacin in the range of <= 0. 25 to >=16ug/ml.
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