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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-MAK-2 PLUS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for hepatitis surface ag (hbs ag)
ApplicantDIASORIN, INC.
PMA NumberP990038
Supplement NumberS007
Date Received04/05/2004
Decision Date04/30/2004
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 quality control specifications related to the positive control od and concentration limits for kit and component release.
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