|
Device | VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S101 |
Date Received | 08/05/1999 |
Decision Date | 12/10/1999 |
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 erythromycin at concentrations of 0.25, 0.5, and 2ug/ml to the Vitek(R) 2 Gram Positive Susceptibility Test System. The device is indicated for use in Vitek(R) 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive isolates to erythromycin in the range of <0.25 to >8ug/ml. |