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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 AXSYM HBSAG
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantAbbott Laboratories, Inc.
100 Abbott Park Rd.
Dept. 9va-Ap8-1
Abbott Park, IL 60064
PMA NumberP050049
Supplement NumberS002
Date Received12/13/2007
Decision Date12/19/2007
Withdrawal Date11/15/2013
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS THAT CLARIFIES THE MEANING OF THE FINAL INTERPRETATION REPEAT REACTIVE, NONCONFORMING FOR HBSAG IN THE AXSYM HBSAG CONFIRMATORY PACKAGE INSERT. ALSO, CHANGES TO THE AXSYM HBSAG PACKAGE INSERT TO ALIGN WITH THE REMOVAL OF THE TERM "REPEAT REACTIVE" FROM THE INTERPRETATION OF RESULTS FOR THE AXSYM HBSAG CONFIRMATORY ASSAYS.
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