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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 CONTROL KIT
Classification Namehepatitis viral b dna detection
Generic Namehepatitis viral b dna detection
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP080026
Supplement NumberS010
Date Received10/21/2013
Decision Date11/19/2013
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MANUFACTURING PROCESS CHANGES AND QC IN-PROCESS METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE.
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