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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 HBE (RDNA) EIA TEST KIT
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Namehepatitis b test (b core, be antigen, be antibod
ApplicantABBOTT LABORATORIES
PMA NumberP790025
Supplement NumberS007
Date Received02/21/1995
Decision Date02/16/1996
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the manufacturing process from the use of recalcified anti-hbe positive human plasma from one donor to the use of an alternate source of anti-hbe positive plasma for bead coating.
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