|
Device | VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S094 |
Date Received | 07/22/1999 |
Decision Date | 10/07/1999 |
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 amikacin at concentrations of 8, 16 and 64 ug/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 amikacin in the range of <2 to >64 ug/ml. |