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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceAbbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit
Generic Namehepatitis viral b dna detection
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP080026
Supplement NumberS021
Date Received06/27/2017
Decision Date09/01/2017
Product Code MKT 
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly.