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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceVITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
Applicant
BIOMERIEUX VITEK, INC.
595 anglum dr.
hazelwood, MO 63042-2395
PMA NumberN50510
Supplement NumberS145
Date Received04/16/2001
Decision Date06/25/2001
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN THE ANTIBIOTIC DESIGN SPECIFICATION FOR THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304, AND 32/608 UG/ML TO THE VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK 2 AND IS INDICATED FOR USE IN VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE ISOLATES TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF <= .5/9.5 TO >= 16/304 UG/ML.
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