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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 NameVIDAS TOTAL PSA
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal prostate specific antigen immunoassay
ApplicantBIOMERIEUX, INC.
PMA NumberP040008
Supplement NumberS006
Date Received02/14/2013
Decision Date03/13/2013
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate alkaline phosphatase (alp) from the same qualified supplier; it also proposed an improvement to the quality controls performed on this material.
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