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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 NumberP990038
Supplement NumberS004
Date Received10/29/2002
Decision Date03/14/2003
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of a diasorin hbsag confirmatory reagent to confirm eti-mak-2 plus repeatedly reactive samples, and use of a diasorin confirmatory reagent specifically in prenatal screening to confirm all eti-mak-2 plus repeatedly reactive samples in the absence of other hbv marker testing. The device, as modified, will be marketed under the trade name diasorin hbsag confirmatory test and is indicated for an in vitro neutralization assay for qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma samples (edta, heparin, and citrate) found to be repeatedly reactive for hbsag by eti-mak-2 plus. This assay has not been fda-approved for the screening of blood or plasma donors.