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 GRAM POSITIVE AST FOR MOXIFLOXACIN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S142 |
Date Received | 12/18/2000 |
Decision Date | 05/30/2001 |
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 TO THE VITEK. GRAM POSITIVE SUSCEPTIBILITY PANELS, THE ANTIBIOTIC MOXIFLOXACIN AT EQUIVALENT CONCENTRATIONS OF 1, 2, AND 4 MCG/ML. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR MOXIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO MOXIFLOXACIN IN THE RANGE OF <=0.25 TO >=8 MCG/ML. |
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