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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDIASORIN ETI MAK-2 PLUS ASSAY
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
Date Received07/02/1999
Decision Date03/30/2001
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 01M-0451
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the diasorin eti-mak-2 plus assay. The device is indicated for: eti-mak-2 plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative determination of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, citrate or heparin). The eti-mak-2 plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of hbsag is indicative of a laboratory diagnosis for hepatitis b virus (hbv) infection, either acute or chronic. Further hbv serological marker testing is required to define the specific disease state. The eti-mak-2 plus assay's performance has not been established for the monitoring of hbv disease or therapy. This assay has not been fda-approved for the screening of blood or plasma donors.
Approval Order Approval Order
Supplements: S002 S003 S004 S005 S006 S007 S008 S010 S011 
S012 S013 S014 S015 S017 S018 S019 S020 
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