|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|
|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 |
Elimination of the in-process chemical testing of the buffer concentrate component of the master mix used with the cobas ampliprep/cobas taqman hbv test, v2. 0 within the fda approved pcr manufacturing center (pmc) facility in branchburg, new jersey.