www.fdanews.com/articles/70524-bayer-gets-fda-approval-for-hepatitis-assay
Bayer Gets FDA Approval for Hepatitis Assay
March 31, 2005
Bayer AG said the diagnostics division of its Bayer HealthCare unit received approval by the FDA for its hepatitis assay. Bayer HealthCare, diagnostics division, a member of the Bayer Group, announced the sixth FDA approved, automated assay for hepatitis on its market leading ADVIA Centaur Immunoassay System. The FDA approved Bayer HealthCare Diagnostics' assay for hepatitis A (HAV) Total, an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the hepatitis A virus in human serum or plasma.