|Trade Name||ELECSYS HBSAG IMMUNOASSAY|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||ROCHE DIAGNOSTICS CORP.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of elecys coated microparticles.