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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 NameNMP22 BLADDERCHEK TEST
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namecarcinoma of urinary tract test kit
ApplicantALERE SCARBOROUGH, INC
PMA NumberP940035
Supplement NumberS009
Date Received03/18/2013
Decision Date04/02/2013
Product Code
NAH[ Registered Establishments with NAH ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increase the manufacturing efficiency of the assembled cassette by modifying the assembly method used in the manufacture of nmp22 bladderchek from assembled and pouched manually by hand by operators, to be assembled by validated automated equipment.
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