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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 NumberS027
Date Received06/09/1998
Decision Date06/30/1998
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a limitation to use an alternative method to confirm results for the testing of staphylococcus spp. With the antibiotic vancomycin. The device, as modified, will be marketed under the trade name microscan(r) rapid fluorogenic.
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