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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 2000 HBS AG CONFIRMATORY KIT
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 NumberS011
Date Received09/29/2010
Decision Date06/24/2011
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 AN AUTOMATED MEANS OF CONFIRMATION TESTING ON-BOARD THE IMMULITE 2000 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 HBSAG CONFIRMATORY KIT AND IS INDICATED FOR: IMMULITE 2000 HBSAG CONFIRMATORY IS INTENDED FOR IN VITRO DIAGNOSTIC USE WITH IMMULITE 2000 ANALYZERS IN CONJUNCTION WITH THE IMMULITE 2000 HBSAG ASSAY - FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE) THAT WERE REPEATEDLY REACTIVE WHEN TESTED BY THE IMMULITE/ IMMULITE 1000 HBSAG ASSAY OR BY THE IMMULITE 2000 HBSAG ASSAY.
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