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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS107
Date Received08/25/1999
Decision Date01/21/2000
Reclassified Date12/28/2001
Product Codes LTW LON 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32, and 64 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the tradename Vitek 2 and is indicated for use in Vitek 2 Gram Negative Susceptibility Test Card for the susceptibility testing of gram negative isolates to nitrofurantoin in the range of <= 16 to >= 512ug/ml.
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