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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.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibodies against hepatitis b core (anti-hbc) hepatitis b surface antigen (hbsag) total antibodies against hepats
PMA NumberP010053
Supplement NumberS007
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-hbc igm assay. The device, as modified, will be marketed under the trade name immulite 2000 xpi anti-hbc igm assay and is indicated for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b virus infections in conjunction with other serological and clinical information.