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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameHBV ASSAY
Classification Namehepatitis viral b dna detection
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP080026
Supplement NumberS006
Date Received02/15/2013
Decision Date10/15/2013
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product 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.
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