|
Device | VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S097 |
Date Received | 07/28/1999 |
Decision Date | 12/03/1999 |
Reclassified Date
|
12/28/2001 |
Product Codes |
LON LTW |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addtion of the antibiotic ampicillin/sulbactam at concentrations of 4/2, 16/8, 32/16ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to ampicillin/sulbactam in the range of <2/1 to >32/16ug/ml. |