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# Hep C virus RNA Devices Reclassified
- URL: https://www.fdaweb.com/hep-c-virus-rna-devices-reclassified/
- Published: 2021-11-22T12:00:00.000Z
- Updated: 2026-09-14T17:23:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150622

*Federal Register* notice: FDA is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, from Class 3 devices (product codes MZP and OBF) into Class 2 (general controls and special controls), subject to premarket notification. FDA is renaming and codifying the devices under the classification regulation named “nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-22/pdf/2021-25379.pdf?ref=fdaweb.com).