|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||COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0|
|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 |
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.