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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP090024
Date Received10/22/2009
Decision Date10/11/2011
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 11M-0737
Notice Date 10/20/2011
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for advia centaur hbeag assay & advia centaur hbeag quality control material. This device is indicated for: advia centaur hbeag assay: the advia centaur hbeag assay is an in-vitro diagnostic immunoassay for the qualitative determination of the hepatitis b e antigen (hbeag) in human serum and plasma (potassium edta, lithium or sodium heparin) from individuals who have signs and symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection using the advia centaur and advia centaur xp systems. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis b virus. Advia centaur hbeag quality control material: the controls are used for monitoring the performance of the hbeag assay on the advia centaur systems. The performance of the hbeag quality control material has not been established with any other hbeag assay.
Approval Order Approval Order
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