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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namecarcinoma of urinary tract test kit
PMA NumberP940035
Date Received11/07/1994
Decision Date07/02/1996
Product Code
NAH[ Registered Establishments with NAH ]
Docket Number 96M-0462
Notice Date 12/09/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the matritech nmp22 test kit. The matritech nmp22 test kit is an enzyme immunoassay (eia) for the in vitro quantitative determination of nuclear matrix protein nmp22 in stabilized voided urine.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011