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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 NameDIASORIN ETI-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 NumberS004
Date Received04/14/2003
Decision Date05/07/2003
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the quantity of non-specific mouse igg used in the preparation of the sample diluent, positive control and negative control kit reagents of the diasorin eti-core-igmk plus.
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