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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAXSYM CORE 2.0
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
Supplement NumberS007
Date Received03/21/2011
Decision Date04/21/2011
Withdrawal Date 11/15/2013
Product Code LOM 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE OF TEST METHOD WITH A DIFFERENT ASSAY FOR DETERMINING ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN SPECIFIC ACTIVITY AND ALLOWING FOR USE OF HIGH TITER IGG IN IN PLACE OF EACH OTHER WHEN THEIR CONCENTRATIONS OVERLAP.
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