MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Primary DI

13 52022 FGMS-NUTRI 1 65

Basic UDI-DI Code

8437024682FGMS-NutriVC

Reference

FGMS-Nutri

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Fagron Genomics

Fagron NutriGen is intended to assist health professionals in making specific care decisions to prevent hereditary health risks related to nutrition. It analyses 109 genetic predispositions with a significant impact on health and nutrition-related parameters and combines this data with the analysis of patient's anamnesis to recommend the most appropriate health and nutritional advice. Genetic data are obtained from commercially validated biomedical assays performed on DNA extracted from buccal swab. Fagron NutriGen uses an automatized qualitative nutrigenetic algorithm that analyses genetic variations associated with risk factors for metabolic syndrome, food intolerances, and deficiencies in minerals and vitamins, among others, and relevant patient’s anamnesis to determine predispositions, predict responses to exercise and to interventional diets and recommend supplementation and nutritional advice in adult male and female populations. Outcomes includes genetic results, recommended personalised supplementation formulas and diet plan.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).