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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) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS139
Date Received04/12/2000
Decision Date06/26/2000
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the antibiotic trimethoprim/sulfamethoxazole at concentrations of 2/38, 8/152, 16/304 and 32/608 micrograms/ml to the vitek(r) 2 s. Pneumoniae susceptibility test system. The device as modified, will be marketed under the trade name vitek(r) 2 s. Pneumoniae susceptibility test cards for use in the vitek(r) 2 system and is indicated for use for the susceptibility testing of streptococcus pneumoniae to trimethoprim/sulfamethoxazole in the range of <=0. 5/9. 5 to >=16/304.
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