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 SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S144 |
Date Received | 01/03/2001 |
Decision Date | 06/13/2001 |
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 QUINUPRISTIN/DALFOPRISTIN AT CONCENTRATIONS OF 0.75, 1.5, AND 3 MCG/ML TO THE VITEK. GRAM POSITIVE SUSCEPTIBILITY PANEL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, VANCOMYCIN-RESISTANT ENTEROCOCCUS FAECIUM, STAPHYLOCOCCUS EPIDERMIDIS, AND STREPTOCOCCUS AGALACTIAE ISOLATE TO QUINUPRISTIN/DALFOPRISTIN IN THE RANGE OF <=.5 TO >=4 MCG/ML. |
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