|
Device | VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S092 |
Date Received | 07/14/1999 |
Decision Date | 11/05/1999 |
Reclassified Date
|
12/28/2001 |
Product Codes |
LON LTW |
Advisory Committee |
Microbiology |
Supplement Type | Normal 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 trimethoprim/sulfamethoxazole at concentrations of 0.5/9.5, 2/38 and 16/304ug/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 trimethoprim/sulfamethoxazole in the range of <1/19 to >16/304ug/ml. |