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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, AUSAB
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
PMA NumberP060003
Date Received02/10/2006
Decision Date08/07/2006
Withdrawal Date 11/15/2013
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0161
Notice Date 04/30/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the axsym ausab assay. The device is indicated for: axsym ausab reagent pack is a microparticle enzyme immunoassay (meia) intended for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in sodium heparin). The assay is used for the quantitative measurement of antibody response to hepatitis b virus (hbv) vaccination for the determination of hbv immune status, and for the diagnosis of hbv disease associated with hbv infection when used in conjunction with other laboratory results and clinical information. The axsym ausab standard calibrators are used for the calibration of the axsym system when the system is used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) using the axsym ausab reagent pack. The performance of the axsym ausab standard calibrators has not been established with any other anti-hbs assays. The axsym ausab controls are used for monitoring the performance of the axsym system (reagent, calibrators, and instrument) when used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) when using the axsym ausab reagent pack. The performance of the axsym ausab controls has not been established with any other anti-hbs assays.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 
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