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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.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
1951 northwestern ave.
stillwater, MN 55082-0285
PMA NumberP990043
Supplement NumberS005
Date Received01/30/2004
Decision Date02/12/2004
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the package insert: the supplement contains a revision in the assay package insert that states "all lots of incubation buffer are interchangeable between eti-ebk plus, eti-ab-ebk plus, eti-ab-havk plus. ".