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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.
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