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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.
 
DeviceARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2, DEPT. 09VB
ABBOTT PARK, IL 60064
PMA NumberP060007
Supplement NumberS011
Date Received03/01/2011
Decision Date03/30/2011
Withdrawal Date 01/09/2014
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
TEST METHOD CHANGE FOR QUANTITATING ANTI-D AND ANTI-Y MONOCLONAL ANTIBODIES WHICH ARE USED IN THE TESTING OF THE RECOMBINANT HBSAG SUBTYPE AD (CODE 98034) AND HBSAG SUBTYPE AY (CODE 98035) ANTIGENS USED IN THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAYS.
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