|
Device | VITEK 2 GRAM POSITIVE AST FOR CEFOTAXIME |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S131 |
Date Received | 04/05/2000 |
Decision Date | 06/06/2000 |
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 CEFOTAXIME AT CONCENTRATIONS OF 0.06, 0.25, 0.5 AND 1 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO CEFOTAXIME IN THE RANGE OF <=0.06 TO >=4 MICROGRAMS/ML. |