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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 POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS145
Date Received04/16/2001
Decision Date06/25/2001
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the antibiotic design specification for the antibiotic trimethoprim/ sulfamethoxazole at concentrations of 2/38, 8/152, 16/304, and 32/608 ug/ml to the vitek 2 gram positive ast panel for streptococcus pneumoniae: trimethoprim/ sulfamethoxazole. The device, as modified, will be marketed under the trade name vitek 2 and is indicated for use in vitek 2 gram positive ast panel for streptococcus pneumoniae for the susceptibility testing of streptococcus pneumoniae isolates to trimethoprim/ sulfamethoxazole in the range of <=. 5/9. 5 to >= 16/304 ug/ml.
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