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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHBSAG
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP010050
Supplement NumberS012
Date Received03/16/2011
Decision Date05/12/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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 hbsag assay. The device, as modified, will be marketed under the trade name immulite 2000 hbsag assay an is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information.
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