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Hep C Tests Down-Classified By FDA

The IVDs, now moderate-risk class II, had been high-risk class III

Executive Summary

Nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests and HCV antibody tests were reclassified as moderate-risk class II by the US FDA on 19 November. The agency says the change could spur competition among makers of in vitro diagnostics.

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