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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 ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for igm ab to hepatitis core antigen
ApplicantDIASORIN, INC.
PMA NumberP990044
Supplement NumberS012
Date Received02/17/2012
Decision Date03/09/2012
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the qc test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
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