# DEN070004: Xpert EV, Model Gxev-100N-10; Genexpert DX System, Models P/N 900-0144, 900-0145, 900-0146, 900-0065

- Pathway: De Novo (Post-NSE)
- Applicant: Cepheid
- Decided: Mar 16, 2007 after 4 days
- Product code: OAI (Assay, Enterovirus Nucleic Acid)
- Device class: 2
- Regulation: 21 CFR 866.3225
- 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/DEN070004
Methodology: https://510kreport.com/methodology