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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 NameARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES
PMA NumberP060007
Supplement NumberS011
Date Received03/02/2011
Decision Date03/30/2011
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 
Test method change for quantitating anti-d and anti-y monoclonal antibodies which are used in the testing of the recombinant hbsag subtype ad (code 98034) and hbsag subtype ay (code 98035) antigens used in the architect hbsag and hbsag confirmatory assays.
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