# K031367: Duopath Verotoxins Glisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Emd Chemicals, Inc.
- Decided: Jan 23, 2004 after 268 days
- Product code: GNA (Antisera, All Types, Escherichia Coli)
- Device class: 1
- Regulation: 21 CFR 866.3255
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Duopath® Verotoxins GLISA test is a rapid test for the qualitative identification of Verotoxins I and II (Shiga-like toxins) produced by E. coli isolated in cultures derived from clinical specimens. The identification aids in the diagnosis of diseases caused by enterohemorrhagic E. coli infections.

Source page: https://510kreport.com/device/K031367
Methodology: https://510kreport.com/methodology