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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.
 
Trade NameAXSYM HBSAG, HGSAG CONFIRMATORY, AND ASXYM HBSAG CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
PMA NumberP050049
Date Received12/06/2005
Decision Date06/01/2006
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0174
Notice Date 05/03/2007
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 the abbott axsym hbsag assay, which is indicated for: axsym hbsag: axsym hbsag is a microparticle enzyme immunoassay (meia) intended for the qualitative detection of hepatitis b surface antigen (hbsag) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium edta, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes). The assay is used as an aid in the diagnosis of acute or chronic hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. The assay may be used to test for hbv infection in pregnant women. Axsym hbsag confirmatory: axsym hbsag confirmatory in s microparticle enzyme immunoassay (meia) intended for the confirmation of the presence of hepatitis b surface antigen (hbsag) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium edta, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes). The assay is used for confirmation of samples found to be repeatedly reactive by the axsym hbsag assay. The assay may be used to confirm hepatitis b virus (hbv) infection in pregnant woman. Axsym hbsag controls: the axsym hbsag positive and negative controls are for use in monitoring the performance of the axsym hbsag reagent kit and the axsym hbsag confirmatory kit. The performance of the axsym hbsag controls have not been established with any other hbsag assays.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 
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