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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.
 
DeviceIMMULITE & IMMULITE 2000 HBSAG ASSAY
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)
Applicant
Siemens Healthcare Diagnostics Products, LTD
glyn rhonwy
llanberis, caernarfon LL55
PMA NumberP010050
Supplement NumberS007
Date Received12/02/2008
Decision Date02/09/2009
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 replacement of the sodium based buffer with potassium phosphatebuffer and addition of 2. 0% normal mouse serum and 1. 2% e-amino-n-caproic acid in reagent a,and the addition of 0. 2% sodium heparin in reagent b followed by refiltering of diluent, and isindicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis bvirus infections in conjunction with other serological and clinical information.
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