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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 NameUROVYSION BLADDER CANCER KIT ASSAY
Classification Nametest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
Generic Namefluorescence in situ hybridization(fish) reagents
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP030052
Supplement NumberS009
Date Received07/13/2012
Decision Date08/10/2012
Product Code
NSD
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Eliminate a second clone identity testing procedure at the fermentation stage for lsi 9p21, qualify the geneprep instrument, qualify the overhead mixing system and validation of mixing process in the manufacture of hybridization buffer, implement the optical density reading as an additional in process quality control, validate an existing mixing process for the urovysion bulk solution, and transfer an existing in-process testing of labeled dna.
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