|Trade Name||AXSYM CORE-M 2.0 (LN 3B89)|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||ABBOTT LABORATORIES INC|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.