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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 NumberS031
Date Received10/12/2001
Decision Date11/09/2001
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to strengthen contraindications to the rapid gram negative procedural manuals for both mic and breakpoint formats, which describes a limitation for performance characteristics for esbl producing organisms and a limitation for those organisms (e. G. , enterobacter species) which express inducible beta-lactamase enzymes.
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