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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 63042-2395
PMA NumberN50510
Supplement NumberS107
Date Received08/25/1999
Decision Date01/21/2000
Reclassified Date 12/28/2001
Product Codes LON LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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