|
Device | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD |
Generic Name | Susceptibility test cards, antimicrobial |
Regulation Number | 866.1640 |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S080 |
Date Received | 04/01/1998 |
Decision Date | 04/14/1998 |
Reclassified Date
|
12/28/2001 |
Product Code |
LTW |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate 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 a limitation to use an alternative method to confirm results for the testing of Pseudomonas aeruginosa with the antibiotic cefepime. The device, as modified, will be marketed under the trade name Vitek Gram Negative Susceptibility Card in three concentrations (equivalent to 4, 8 and 16 ug/ml) and is indciated for the testing of rapidly growing aerobic and/or facultatively anaerobic gram negative bacilli. |