|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||ABBOTT REALTIME HBV|
|Classification Name||hepatitis viral b dna detection |
|Applicant||ABBOTT MOLECULAR, INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the manufacturing process for oligonucleotides and the addition of two new suppliers for a raw material.