CRC-01-1250-01

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

08437023437018

Basic UDI-DI

B-08437023437018

Numéro de référence/catalogue

CRC-01-1250-01

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

RAID-CRC (Risk-Assessment Intestinal Disease – Colorectal Cancer) is a non-invasive tool based on faecal bacterial markers to differentiate subjects with advanced colorectal neoplasia (advanced adenoma and/or colorectal cancer (CRC)) from subjects with normal colonoscopy and non-advanced adenomas, composed of 8 species or groups that have been related with both favourable and unfavourable aspects of intestinal health by recent scientific literature. Two variants of the RAID-CRC test/kit exist according to its target population, which are subjects at intermediate or high risk of suffering from CRC, defined as follows: 1. Screening population. Asymptomatic subjects aged between 50 and 69 (both included), who obtained a positive result in the faecal immunochemical test (FIT) in the Catalan CRC screening programme. The FIT cut-off from which patients were considered positive was 20 μg haemoglobin/g of faeces (FIT20). This population was used to develop RAID-CRC Screen kit. 2. Symptomatic population. Subjects that showed any symptom related to the presence of CRC. These symptoms are presence of blood in stool, unexplained tiredness, unexplained weight loss, changes in bowel habits, and abdominal pain. This population was used to develop RAID-CRC Symptomatic kit.

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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