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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 SOFTWARE V4.0 SP1 ANTI-HBCT
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 HEALTHCARE DIAGNOSTICS
PMA NumberP040004
Supplement NumberS005
Date Received03/31/2009
Decision Date08/20/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval fot the advia centaur system software version 4. 0.
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