# DEN110001: Norovirus Serological Reagent

- Pathway: De Novo
- Applicant: unknown
- Decided: —
- Product code: OUC (Norovirus Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3395
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 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
- K110968: Proflu+ Assay (2011), 15 descendants of its own
- K132129: Prodesse Proflu+ Assay (2013), 13 descendants of its own
- K142045: Xpert Flu/RSV XC Assay (2014), 5 descendants of its own
- K153544: cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System (2016), 4 descendants of its own
- K151226: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (2015), 4 descendants of its own

Source page: https://510kreport.com/device/DEN110001
Methodology: https://510kreport.com/methodology