|Trade Name||COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0|
|Applicant||Roche Molecular Systems, Inc.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Discontinuation of final bulk testing requirements for bulk quantitation standard (qs) and internal control (ic) reagents for 17 qs/ic products used with the associated assays.