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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-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT
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 NumberS013
Date Received11/13/2009
Decision Date05/21/2010
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing bsa raw material.
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