|
Device | VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S113 |
Date Received | 08/30/1999 |
Decision Date | 02/08/2000 |
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 The addition of the antibiotic streptomycin at a concentration of 1000mg/ml to the Vitek 2 Gram Positive Susceptibility Test System. |