|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|
|Generic Name||cobas taqman hbv test for use with the high pure system|
|Applicant||ROCHE MOLECULAR SYSTEMS, INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Scale-up of a manufacturing process.