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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.
 
DeviceIMMULITE & IMMULITE 2000 HBSAG ASSAY
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
GLYN RHONWY
LLANBERIS, CAERNARFON LL55
PMA NumberP010050
Supplement NumberS007
Date Received12/02/2008
Decision Date02/09/2009
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REPLACEMENT OF THE SODIUM BASED BUFFER WITH POTASSIUM PHOSPHATEBUFFER AND ADDITION OF 2.0% NORMAL MOUSE SERUM AND 1.2% E-AMINO-N-CAPROIC ACID IN REAGENT A,AND THE ADDITION OF 0.2% SODIUM HEPARIN IN REAGENT B FOLLOWED BY REFILTERING OF DILUENT, AND ISINDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS BVIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.
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