|Trade Name||HBV ASSAY|
|Classification Name||hepatitis viral b dna detection |
|Applicant||ABBOTT MOLECULAR, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 1) the addition of an optional extended use feature to allow prepared amplification master mix and internal control to be used second time within 14 days of initial use if stored at 2°c to 8°c; 2) improvements to the preparation and processing steps of the amplification master mix by the abbott m2000sp instrument; and 3) associated software revisions.