Bayer HealthCare Diagnostics

FDA approves hepatitis B assay

Published in Physician Law Weekly, September 8th, 2004

The Diagnostics Professional Testing Systems Division of Bayer HealthCare LLC, a member of the Bayer Group (BAY) announced that it has received U.S. Food and Drug Administration (FDA) approval for its second hepatitis B assay on the Advia Centaur Immunoassay System in 11 weeks.

The Anti-HBc-IgM assay, a fully automated test on its leading automated immunoassay platform - the Advia Centaur Immunoassay System, is used to aid in the diagnosis of hepatitis B virus (HBV) infections.

"The availability of the Anti-HBc-IgM assay is another step for Bayer in offering customers a total solution for their infectious disease testing panel which will ultimately...

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Source: Physician Law Weekly (2004-09-08)

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