|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|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Scale-up of a manufacturing process.