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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
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 NumberS006
Date Received12/02/1994
Decision Date05/17/1996
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the product labeling to enhance the safety in the use of the abbott hbe (rdna) eia. The limitations section will be modified tostate that "samples containing rheumatoid factor amy demonstrate falsely elevated values in the hbeag assay," and the interpretation of results section will be modified tostate that "it is recommended that patients be screened for the presence of hbsag prior to being evaluated for the presence of hbeag. ".
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