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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 NameABBOTT ARCHITECT AUSAB
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
PMA NumberP050051
Date Received12/09/2005
Decision Date06/01/2006
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 06M-0321
Notice Date 08/17/2006
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 architect ausab reagent kit, which is indicated for: architect ausab reagent kit: the architect ausab assay is a chemiluminescent microparticle immunoassay (cmia) for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in human adult and pediatric serum and plasma (dipotassium edta, lithium heparin, and sodium heparin) and neonatal serum. It is intended for quantitative measurement of antibody response following hepatitis b virus (hbv) vaccination, determination of hbv immune status, and for the laboratory diagnosis of hbv disease associated with hbv infection when used in conjunction with other laboratory results and clinical information. Architect ausab calibrators: the architect ausab calibrators are used to calibrate the architect i system when the system is used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) using the architect ausab reagent kit. The performance of the architect ausab calibrators has not been established with any other anti- hbs assays. Architect ausab controls: the architect ausab controls are used for monitoring the performance of the architect i system when used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) using the architect ausab reagent kit. The performance of the architect 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 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 
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