# DEN160016: Variola virus Real-Time PCR Assay

- Pathway: De Novo (Direct)
- Applicant: Centers For Disease Control and Prevention (CDC)
- Decided: Feb 6, 2017 after 298 days
- Product code: PRA (Variola Virus Nucleic Acid-Based Detection Assay)
- Device class: 2
- Regulation: 21 CFR 866.3316
- 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/DEN160016
Methodology: https://510kreport.com/methodology