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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(R) RAPID FLUOROGENIC PANELS
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantDADE INTL., INC.
PMA NumberP870049
Supplement NumberS030
Date Received05/17/2000
Decision Date06/05/2000
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 labeling change that adds a contraindication to the gram negative microscan rapid fluorogenic panels of "do not report" when testing all gram negative organisms with cefoperazone using either the mic or breakpoint formats.
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