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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 NameABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES
PMA NumberP060007
Supplement NumberS020
Date Received08/17/2012
Decision Date09/14/2012
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 
Change to a test method used in the manufacture of the components of the architect hbsag and hbsag confirmatory assay, and the architect hbsag.
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