# DEN030004: West Nile Virus Igm Capture Elisa

- Pathway: De Novo (Post-NSE)
- Applicant: Panbio Limited
- Decided: Jul 8, 2003 after 5 days
- Product code: NOP (Elisa, Antibody, West Nile Virus)
- Device class: 2
- Regulation: 21 CFR 866.3940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K041231: West Nile Virus Igm Capture Elisa, Model E-WNV02M (2004), 0 descendants of its own

Source page: https://510kreport.com/device/DEN030004
Methodology: https://510kreport.com/methodology