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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) GRAM POSITIVE AST FOR NITROFURANTOIN
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS116
Date Received09/15/1999
Decision Date02/08/2000
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 addition of the antibiotic nitrofurantoin at concentration fo 16,32 and 64 mg/ml to the vitek 2 gram positive susceptibility test system.
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