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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-AB-COREK PLUS ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for total antibodies to hepatitis b core antigen
ApplicantDIASORIN, INC.
PMA NumberP990045
Supplement NumberS005
Date Received10/20/2003
Decision Date11/26/2003
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extension of the eti-ab-corek plus assay expiration dating from 7 months and a minor labeling change in the analytical sensitivity section of the package insert to correct a calculation error.
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