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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
AP5N-2, DEPT. 09VB
ABBOTT PARK, IL 60064
PMA NumberP060012
Date Received03/24/2006
Decision Date09/08/2006
Withdrawal Date 11/15/2013
Product Code LOM 
Docket Number 07M-0153
Notice Date 04/19/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS. THIS DEVICE IS INDICATED FOR: THE AXSYM CORE 2.0 IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES (IGG AND IGM) TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI HBC) IN 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 CONTAINING LITHIUM HEPARIN). THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE, CHRONIC, OR RESOLVED HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE THE AXSYM CORE 2.0 CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT AND INSTRUMENT) WHEN USED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI HBC) WHEN USING THE AXSYM CORE 2.0 REAGENT KIT. THE PERFORMANCE OF THE AXSYM CORE 2.0 CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S006 S007 S008 S010 S004 S005 S002 S009 S003 S001 
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