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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
ApplicantBIOMERIEUX SA
PMA NumberP040008
Supplement NumberS011
Date Received03/23/2015
Decision Date04/22/2015
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 
Change to remove extraneous in-process stability tests performed on the strips (str) and on the solid phase receptacles (spr) of the kit, and consequently to add an instruction for the storage of the str during the manufacturing process.
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