Bayer hepatitis B diagnostic
This article was originally published in The Gray Sheet
Executive Summary
FDA approves PMA for firm's automated hepatitis B surface antigen assays May 26 for use on Bayer's Advia Centaur immunoassay system. With the approval, Bayer now claims to have the industry's only complete panel for acute hepatitis A, B, and C testing (1"The Gray Sheet" Jan. 24, 2005, p. 15). Other automated platforms with hepatitis test kits include Abbott's AxSym and J&J/Ortho-Clinical Diagnostics' Vitro ECi...
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