RAID-Dx

Primary DI

08437023437049

Basic UDI-DI Code

B-08437023437049

Reference

DX-02-2024-01-HP

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GOODGUT, SLU

IVD to Professional use only. RAID-Dx is a test for the diagnosis of irritable bowel syndrome and differentiating it from inflammatory bowel diseases based on a faecal microbial signature. The device is derived directly from GoodGut's know-how, as well as from the patent generated from it (PCT/EP2016/069188) in which a method for the quantification of Faecalibacterium prausnitzii, phylogroup I and/or phylogroup II, and its use as markers for intestinal disease diagnosis is described. The use of the other markers that are included in the RAID-Dx test is justified by the most current knowledge about the relationship between the gut microbiota and different intestinal disorders, together with subsequent performance studies both analytical and clinical derived from the most recent scientific literature. 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).