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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 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 NumberS007
Date Received02/22/2012
Decision Date11/13/2012
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification of the quality control testing specification for the 400 miu/ml calibrator in the device.
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