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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.
 
Trade NameMICROSCAN RAPID FLUOROGENIC PANELS
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantDADE INTL., INC.
PMA NumberP870049
Supplement NumberS028
Date Received01/04/1999
Decision Date01/25/1999
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a limitation to use an alternative method for testing of proteus mirabilis and enterobacter spp. With the antibiotic cefazolin in either the minimal inhibitory concentration (mic) or the breakpoint panels.
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