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# FDA Reclassifying Some Hepatitis Tests
- URL: https://www.fdaweb.com/fda-reclassifying-some-hepatitis-tests/
- Published: 2020-04-02T12:00:00.000Z
- Updated: 2026-09-14T16:09:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146480

*Federal Register* notice: FDA is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV from Class 3 (product code MZO) to Class 2 (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “hepatitis C virus (HCV) antibody tests.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-04-02/pdf/2020-06821.pdf?ref=fdaweb.com).