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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 NameMONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantBIO-RAD LABORATORIES
PMA NumberP050048
Supplement NumberS005
Date Received06/17/2010
Decision Date11/23/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at bio-rad laboratories in woodinville, washington.
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