RAID-Dx

Primary DI

08437023437032

Basic UDI-DI Code

B-08437023437032

Reference

DX-02-1024-01-LP

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GOODGUT, SLU

RAID-Dx test is based on a patented technology that detects a combination of microbial markers analysed in faecal samples. It is composed of 9 markers composing different taxonomic groups: Faecalibacterium prausnitzii, F. prausnitzii phylogroup I and phylogroup II, Escherichia coli, Akkermansia muciniphila, Methanobrevibacter smithii, Ruminococcus sp., Bacteroidetes, and Eubacteria. The results are obtained by qPCR, where the abundance of the microbial markers is obtained by amplifying characteristic gene fragments of each taxon or species analysed. The qualitative result is obtained after applying a mathematical algorithm that combines the 9 described microbial markers. Target population The target population of RAID-Dx will be subjects who present abdominal pain, depositional alteration and/or who meet Rome IV criteria, symptomatology compatible with Irritable Bowel Syndrome (IBS). As these symptoms are common for both IBS and Inflammatory Bowel Disease, it is necessary to perform a differential diagnosis between them in order to prescribe the most appropriate medical guideline.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).