|
Device | VITEK 2 GRAM NEGATIVE AST FOR CEFOTETAN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S095 |
Date Received | 07/22/1999 |
Decision Date | 11/08/1999 |
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 addition of the antibiotic cefotetan at concentrations of 2, 8, and 32 ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System. This device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testingo f gram negative isolates to cefotetan int he range of <4 to >64ug/ml. |