|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 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 |
Replacement of tetrazole, an activator use din the automated dna synthesis of rms oligonucleotides use in the cobas taqman hbv test for use with the high pure system with the activator 4,5 dicyanoimidazole (dci).