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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-EBK PLUS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for antibody to hepatitis be antigen
ApplicantDIASORIN, INC.
PMA NumberP990041
Supplement NumberS005
Date Received03/11/2004
Decision Date03/26/2004
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 quality control test of an incoming raw material used in the preparation of coated strips of the eti-ab-ebk plus which is an in vitro enzyme immunoassay intended for use in the qualitative determination of total antibodies to hepatitis b e antigen in human serum or plasma.
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