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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 NameETI-CORE-IGMK PLUS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for igm ab to hepatitis core antigen
ApplicantDIASORIN
PMA NumberP990044
Supplement NumberS001
Date Received01/07/2002
Decision Date03/06/2002
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for inclusion of reproducibility studies in the package insert.
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