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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 ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP010054
Supplement NumberS002
Date Received09/15/2005
Decision Date10/06/2005
Reclassified Date10/20/2025
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
Approval Order Statement  
APPROVAL FOR CHANGE IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, OR OTHERWISE PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH, OR RELIABILITY OF THE ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS.
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