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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 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.
 
DeviceVITEK 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL
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 NumberS132
Date Received04/05/2000
Decision Date06/08/2000
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 THE ADDITION OF THE ANTIBIOTIC CHLORAMPHENICOL AT CONCENTRATIONS OF 2, 8 AND 16 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO CHLORAMPHENICOL IN THE RANGE OF <=2 TO >=32 MICROGRAMS/ML.
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