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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 Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Siemens Healthcare Diagnostics Products, LTD
glyn rhonwy
llanberis, caernarfon LL55
PMA NumberP010050
Supplement NumberS011
Date Received09/29/2010
Decision Date06/24/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.