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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)
333 coney street
walpole, MA 02032-1516
PMA NumberP040004
Date Received01/30/2004
Decision Date12/22/2004
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 05M-0109
Notice Date 03/21/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the advia centaur hbc total. Hbc total readypack reagents: the advia centaur hbc total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in human serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur system. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv-infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Hbc total quality control materials: the controls are indicated for in vitro diagnostic use in monitoring the performance of the hbc total assay on the advia centaur systems. The performance of the hbc total quality control material has not been established with any other anti-hbc total assays.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012