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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(R) 2 GRAM NEGATIVE AST FOR IMIPENEM
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS129
Date Received03/09/2000
Decision Date04/26/2000
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device, as modified, will be marketed under the trade name vitek 2 gram negative susceptibility test cards. Approval for the addition of the antibiotic imipenem at concentrations of 2, 4 and 16 micrograms/ml to the vitek 2 gram negative susceptibility test system.
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