|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 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||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Transfer of the rework activities for the elecsys reagent kits from building r to building w2 on the indianapolis campus.