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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 NameBIO-RAD MONOLISA ANTI-HBS EIA
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantBIO-RAD LABORATORIES
PMA NumberP050048
Supplement NumberS002
Date Received09/30/2008
Decision Date03/12/2010
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 the monolisa anti-hbs eia package insert in order to add the statement that allows storage of the working conjugate solution at room temperature for 30 hours, with up to 10 cycles of 3 hours at room temperature allowed.
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