|Trade Name||ELECSYS ANTI-HBC IGM ON COBAS E 411|
|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 a transfer of a portion of the manufacturing operations for the bulk solutions of reagents r1 and r2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.