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# Transplant Viral Nucleic Acid Tests in Class 2
- URL: https://www.fdaweb.com/transplant-viral-nucleic-acid-tests-in-class-2/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157792

*Federal Register* notice: FDA is classifying quantitative viral nucleic acid tests for transplant patient management into Class 2 (special controls). The action was based on a 2020 Roche Molecular Systems request for *de novo* classification of its cobas EBV. The agency says the device is intended for prescription use in detecting viral pathogens by measuring viral deoxyribonucleic acid or ribonucleic acid using specified specimen processing, amplification, and detection instrumentation. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-09-17/pdf/2024-21086.pdf?ref=fdaweb.com).