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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 HBSAG (HBS) ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP030049
Supplement NumberS011
Date Received08/13/2014
Decision Date10/28/2014
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of two washes of the ancillary probe on the advia centaur and advia centaur xp instruments when the advia centaur hbsag assay is run immediately following the advia centaur syphilis assay.
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