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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 TICARCILLIN
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1645
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS112
Date Received08/30/1999
Decision Date02/01/2000
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The additioin of the antibiotic ticarcillin at concentrations of 16, 32, and 64mg/ml to the vitek 2 gram negative susceptibility test system.
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