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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
595 anglum dr.
hazelwood, MO 63042-2395
PMA NumberN50510
Supplement NumberS091
Date Received07/02/1999
Decision Date09/23/1999
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the antibiotic ciprofloxacin at concentrations of 0.5, 2 and 4 ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System. the device, as modified, will be marketed under the trade name Vitek(R) 2 and is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to ciprofloxacin in the range of <0.25 to >4 ug/ml.