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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 NameADVIA CENTAUR HBC TOTAL ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibody to hepatitis b core antigen(anti-hbc total assay)
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP040004
Supplement NumberS008
Date Received01/09/2012
Decision Date02/03/2012
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Adding an in-process step to the preparation of the labeled antigen.
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