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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAXSYM CORE 2.0
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
PMA NumberP060012
Supplement NumberS007
Date Received03/21/2011
Decision Date04/21/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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