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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 TEST KIT
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Dept:09va Bldg: Ap6c-2
Abbott Park, IL 60064
PMA NumberP790025
Supplement NumberS007
Date Received02/21/1995
Decision Date02/16/1996
Withdrawal Date03/22/2007
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS FROM THE USE OF RECALCIFIED ANTI-HBE POSITIVE HUMAN PLASMA FROM ONE DONOR TO THE USE OF AN ALTERNATE SOURCE OF ANTI-HBE POSITIVE PLASMA FOR BEAD COATING
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