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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 NumberP030049
Date Received11/28/2003
Decision Date05/26/2005
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 05M-0270
Notice Date 07/01/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the advia centaur hbsag readypack reagents, advia centaur hbsag confirmatory readypack reagents, and advia centaur hbsag quality control material: advia centaur hbsag ready pack indications for use: the advia centaur hbsag assay is an in vitro immunoassay for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (potassium edta, lithium or sodium heparinized) using the advia centaur system. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infections. The assay may also be used to screen for hepatitis b infection in pregnant women to identify neonates who are at risk of acquiring hepatitis b during the perinatal period. Advia centaur hbsag confirmatory ready pack indication for use: the advia centaur hbsag confirmatory assay is an in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, lithium or sodium heparin) using the advia centaur system. The assay is intended to be used to confirm the presence of hbsag in samples that are repeatedly reactive using the advia centaur hbsag assay. Advia centaur hbsag quality control material indications for use: for monitoring the performance of the hbsag and hbsag confirmatory assays on the advia centaur systems.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002 S003 S004 S005 S006 S007 S008 S010 S011