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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(TM) TEST
Generic NameSystem, test, tumor marker, for detection of bladder cancer
ApplicantAbbott Diagnostics Scarborough, Inc.
10 Southgate Rd.
Scarborough, ME 04074
PMA NumberP940035
Supplement NumberS012
Date Received04/06/2016
Decision Date05/06/2016
Product Code NAH 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in the manufacturing process of the Alere NMP22 Test, in which the manufacture of the antigens used in the manufacture of the urine calibrators and urine controls has been outsourced to a Third Party Vendor.
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