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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 FOR SPARFLOXACIN
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS141
Date Received11/16/2000
Decision Date05/14/2001
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the antibiotic sparfloxacin at concentrations of 0. 5, 1. 0, and 8. 0 mcg/ml to the vitek. 2 gram positive susceptibility test system. The device, as modified, will be marketed under the trade name vitek. 2 gram positive ast for sparfloxacin and is indicated for use in vitek. 2 gram positive susceptibility test cards for the susceptibility testing of staphylococcus aureus isolates to sparfloxacin in the range of <= 0. 25 to >= 8 mcg/ml.
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