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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 HBE (RDNA) EIA
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
DEPT: 09VA BLDG: AP6C-2
ABBOTT PARK, IL 60064-3500
PMA NumberP790025
Supplement NumberS006
Date Received12/02/1994
Decision Date05/17/1996
Withdrawal Date 03/22/2007
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE PRODUCT LABELING TO ENHANCE THE SAFETY IN THE USE OF THE ABBOTT HBE (RDNA) EIA. THE LIMITATIONS SECTION WILL BE MODIFIED TOSTATE THAT "SAMPLES CONTAINING RHEUMATOID FACTOR AMY DEMONSTRATE FALSELY ELEVATED VALUES IN THE HBEAG ASSAY," AND THE INTERPRETATION OF RESULTS SECTION WILL BE MODIFIED TOSTATE THAT "IT IS RECOMMENDED THAT PATIENTS BE SCREENED FOR THE PRESENCE OF HBSAG PRIOR TO BEING EVALUATED FOR THE PRESENCE OF HBEAG."
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