Abbott’s Hep C Architect
This article was originally published in The Gray Sheet
Executive Summary
Firm submits PMA application for an anti-hepatitis C virus test for use on the Architectanalyzer. It would be the first hepatitis assay approved for this platform in the U.S. Abbott markets a hepatitis C and two hepatitis A assays for its AxSYM platform, and the firm recently announced approval of its HBCore assay for its Prism automated blood supply testing system (1"The Gray Sheet" Oct. 31, 2005, In Brief)...
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Abbott's Prism automated blood supply testing platform was launched Oct. 13 following FDA approval of the HBcore assay, the system's first test menu option, for hepatitis core antigen. Additional hepatitis and HIV assays are currently under agency review. The Prism platform has been available outside of the U.S. for over 10 years, but the firm's 1999 consent decree delayed the approval of assay products produced at its Lake County, Ill. manufacturing facility (1"The Gray Sheet" May 20, 2002, p. 17). Units have already been shipped to 10 blood bank customers...
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