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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
511 benedict avenue
tarrytown, NY 10591
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
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 andsymptoms 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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002