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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.
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameprostate specific antigen assay (psa)
PMA NumberP950021
Supplement NumberS007
Date Received07/28/2005
Decision Date10/07/2005
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for transfer of the assay to a new bayer platform, the advia centaur cp system. The advia centaur cp psa assay is intended to quantitatively measure prostate-specific-antigen (psa) in human serum using the advia centaur cp system.