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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 FREE PSA (FPSA) ASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantBIOMERIEUX, INC.
PMA NumberP080008
Supplement NumberS001
Date Received01/09/2012
Decision Date02/08/2012
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an alternate supplier of the critical component solid phase receptacle (spr-pm) for the vidas® total psa and free psa products.
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