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.