|Trade Name||COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0|
|Generic Name||cobas taqman hbv test for use with the high pure system|
|Applicant||ROCHE MOLECULAR SYSTEMS, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Clean in place cycle changes and minor equipment modifications for the two large scale bulk formulation (lsbf) 10,000 l tanks and their associated filling transfer line within the fda approved pcr manufacturing center facility in branchburg, new jersey.