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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceALERE NMP22 BLADDERCHEK TEST
Generic NameSystem, test, tumor marker, for detection of bladder cancer
ApplicantAbbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074
PMA NumberP940035
Supplement NumberS011
Date Received07/01/2015
Decision Date07/28/2015
Product Code NAH 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS OF THE ALERE NMP22 BLADDERCHEK TEST, IN WHICH HEAT TREATED NORMAL MOUSE SERUM IS USED INSTEAD OF NORMAL MOUSE SERUM AS A CONTROL TEST LINE BLOCKING AGENT.
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