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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)
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 - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacement of the sodium based buffer with potassium phosphate buffer 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 is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information.