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Roche Molecular Systems

This article was originally published in The Gray Sheet

Executive Summary

Files export request application with FDA for its Amplicor Hepatitis C virus (HCV) PCR test, according to a Dec. 15 Federal Register notice. Roche is asking for approval to export the test, which uses nucleic acid amplification and nucleic acid hybridization to detect HCV in human plasma and serum, to Australia, Belgium, Canada, Denmark, Germany, Ireland, Italy, Japan, Luxembourg, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom
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