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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 KIT
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namecarcinoma of urinary tract test kit
ApplicantMATRITECH, INC.
PMA NumberP940035
Supplement NumberS003
Date Received09/16/2002
Decision Date04/25/2003
Product Code
NAH[ Registered Establishments with NAH ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new test format to be manufactured at matritech, inc. , newton, massachusetts and at a new facility, unotech diagnostics, inc. , san leandro, california. The device, as modified, will be marketed under the trade name nmp22 bladderchek kit and is indicated for the following: the matritech nmp22 bladderchek test is an in vitro immunoassay intended for the qualitative detection of nmp22 nuclear matrix protein in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. This test is indicated for professional use and prescription home use as an aid in diagnosing and monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.
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