# DEN120012: CDC Denv-1-4 Real Time RT-PCT Assay

- Pathway: De Novo (Post-NSE)
- Applicant: Centers for Disease Control and Prevention
- Decided: May 24, 2012 after 73 days
- Product code: OZB (Dengue Nucleic Acid Amplification Assay (Naat))
- Device class: 2
- Regulation: 21 CFR 866.3946
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

Source page: https://510kreport.com/device/DEN120012
Methodology: https://510kreport.com/methodology