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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 NameANTI-HBS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibodies against hepatitis b core antigen (anti-hbc) hepatitis b surface antigen (hbsag) total antibodies againa
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP010052
Supplement NumberS008
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 - component
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 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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