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New Products In Brief

This article was originally published in The Gray Sheet

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Roche hepatitis C assay: Roche Diagnostics will start shipping its Elecsys Anti-HCV antibody to hepatitis C virus assay, indicated for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma, in July, the firm announced May 28. FDA granted PMA approvals for use of the test on three platforms: the stand-alone cobas e 411 analyzer for low-volume testing; and the cobas e 601 and Modular Analytics E 170 analyzers for mid- and high-volume testing, respectively. The anti-HCV assay is an 18-minute test designed for use with Roche's electrochemiluminescence technology. Roche received 510(k) clearance for another immunoassay, Rubella IgM, in April ("1The Gray Sheet" April 12, 2010)

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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