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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 CEFAZOLIN
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS126
Date Received10/25/1999
Decision Date03/31/2000
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 
This device will be marketed under the tradename vitek 2 and adds the antibiotic cefazolin at concentrations 4,8,and 16 micrograms per millileter to the vitek 2 gram positive susceptibility test system.
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