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# Hep C Virus Antibody Assays Reclassified
- URL: https://www.fdaweb.com/hep-c-virus-antibody-assays-reclassified/
- Published: 2021-11-22T12:00:00.000Z
- Updated: 2026-09-14T17:23:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150621

*Federal Register* notice: FDA is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, from Class 3 devices (product code MZO) into Class 2 (general controls and special controls), subject to premarket notification. FDA is also renaming and codifying the devices “hepatitis C virus (HCV) antibody tests.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-22/pdf/2021-25374.pdf?ref=fdaweb.com).