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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.
 
DeviceELECSYS HBSAG TEST SYSTEM
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis, IN 46250
PMA NumberP990012
Supplement NumberS005
Date Received09/04/2007
Decision Date11/13/2008
Withdrawal Date05/05/2021
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE EXTENSION OF THE ELECSYS HBSAG TEST SYSTEM AND THE ELECSYS ANTI-HBS TEST SYSTEM ONTO THE UPDATED MODEL OF THE ELECSYS 2010 ANALYZER, KNOWN AS THE COBAS E 411 ANALYZER.
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