Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S106 |
Date Received | 08/20/1999 |
Decision Date | 01/10/2000 |
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 Approval for the addition of the antibiotic levofloxacin at concentrations of 0.25, 2 and 8ug/ml to the Vitek 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organism to levofloxacin in the range of <=.125 to >= 8ug/ml. |
|
|