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This article was originally published in The Gray Sheet

Executive Summary

Hepatitis C virus microparticle enzyme immunoassay is approvable for the qualitative detection of HCV antibody in human serum or plasma, FDA's Microbiology Devices Panel unanimously (7-0) recommends Jan. 21. However, labeling must include a "clear and prominent" statement that confirmatory testing should occur after a positive result, as well as data tables showing test patient populations to explain the origin of the clinical testing results, panel says
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