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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 GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS144
Date Received01/03/2001
Decision Date06/13/2001
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 quinupristin/ dalfopristin at concentrations of 0. 75, 1. 5, and 3 mcg/ml to the vitek. Gram positive susceptibility panel. The device will be marketed under the trade name vitek. Gram positive susceptibility (gps) card for quinupristin/ dalfopristin, and is indicated for use in vitek. Gram positive susceptibility test cards for the susceptibility testing of methicillin-susceptible staphylococcus aureus, vancomycin-resistant enterococcus faecium, staphylococcus epidermidis, and streptococcus agalactiae isolate to quinupristin/ dalfopristin in the range of <=. 5 to >=4 mcg/ml.
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