DX-02-2024-01-HP

Nom de l'organisation

GOODGUT, SLU

SRN

ES-MF-000000229

Statut du fabricant

Actif

Marché principal en Espagne ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08437023437049

Basic UDI-DI

B-08437023437049

Numéro de référence/catalogue

DX-02-2024-01-HP

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Intender User. Professional User only. The RAID-Dx qPCR Kit is intended for diagnosing irritable bowel syndrome and performing its differential diagnosis from inflammatory bowel disease, through the detection of specific microbial markers in DNA samples extracted from patients’ faeces. The in vitro RAID-Dx qPCR Kit diagnostic test is based on the qPCR analysis of a panel of faecal microorganisms that are indicators of both favourable and unfavourable intestinal health conditions. The panel is made up of 9 biomarkers representing different species, phylogroups, genera, and other taxa: Faecalibacterium prausnitzii, F. prausnitzii phylogroup I and F. prausnitzii phylogroup II, Escherichia coli, Akkermansia muciniphila, Ruminococcus sp., Methanobrevibacter smithii, Bacteroidetes, and Eubacteria. The qPCR Kit allows the amplification and quantification of characteristic gene fragments of the mentioned microorganisms. Results are given in a report both qualitatively and quantitatively.

URL des informations complémentaires

https://professionalarea.goodgut.eu/documentos/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0101060399FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER

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