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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 NameABBOTT REALTIME HBV
Classification Namehepatitis viral b dna detection
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP080026
Supplement NumberS007
Date Received05/02/2013
Decision Date05/28/2013
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the sampling plan for the reagent vial filling procedure for both devices.
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