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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.
 
DeviceANTI-HBS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
GLYN RHONWY
LLANBERIS, CAERNARFON LL55
PMA NumberP010052
Supplement NumberS008
Date Received02/18/2011
Decision Date05/12/2011
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL, THE IMMULITE 2000 XPI ANALYZER, AS A NEW FAMILY MEMBER OF THE CURRENTLY APPROVED IMMULITE 2000 ANALYZER, TO BE USED WITH THE CURRENTLY APPROVED IMMULITE 2000 ANTI-HBS ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE IMMULITE 2000 XPI ANTI-HBS ASSAY AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE DETECTION OF ANTI-HBS AND IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.
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