# Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management
> **Food and Drug Administration** · Final amendment; final order. · Published 2024-09-23 · Effective 2024-10-23 · 89 FR 77448
## Document
- **Document number:** 2024-21616
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 77448
- **CFR reference:** 21 CFR 866
- **Publication date:** 2024-09-23
- **Effective date:** 2024-10-23
- **HHS docket:** Docket No. FDA-2016-N-2880
## Abstract

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2024/09/23/2024-21616/microbiology-devices-reclassification-of-cytomegalovirus-deoxyribonucleic-acid-quantitative-assay)
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