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. |
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Device | VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S141 |
Date Received | 11/16/2000 |
Decision Date | 05/14/2001 |
Reclassified Date
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12/28/2001 |
Product Codes |
LON LTW |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC SPARFLOXACIN AT CONCENTRATIONS OF 0.5, 1.0, AND 8.0 MCG/ML TO THE VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK. 2 GRAM POSITIVE AST FOR SPARFLOXACIN AND IS INDICATED FOR USE IN VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO SPARFLOXACIN IN THE RANGE OF <= 0.25 TO >= 8 MCG/ML. |
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