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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 IMMULITE ASSAY
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 HEALTHCARE DIAGNOSTICS
PMA NumberP010052
Supplement NumberS009
Date Received08/08/2011
Decision Date09/02/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Full automation of the filling and packaging line for the immulite chemiluminescent substrate reagent, accessory used with all the immulite assays.
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