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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.
DeviceAXSYM CORE 2.0
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
100 abbott park road
ap5n-2, dept. 09vb
abbott park, IL 60064
PMA NumberP060012
Supplement NumberS003
Date Received09/21/2010
Decision Date10/20/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the manufacturing process and quality control test method for the hbcag solutio nand the change to the manufacturing process for the qualified rhbcag used in the axsym core 2. 0 assay.