MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Primary DI

13 52022 FGMS-TELO 1 16

Basic UDI-DI Code

8437024682FGMS-TeloT3

Reference

FGMS-Telo

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Fagron Genomics

Fagron TeloTest is intended to assist health professionals in making patient-specific care decisions regarding the prevention of cellular aging, especially in high yield diagnostic settings, such as suspected cases of short telomere syndromes, genetic variation in telomere genes, and in the evaluation of bone marrow failure and related disorders. It analyses quantitative data associated with the length of telomeres that tend to shorten with age. Quantitative data are obtained from a specific laboratory telomere length assay performed on DNA extracted from buccal swab. Fagron TeloTest uses an automatized qualitative algorithm that calculates telomere length, infer biological age based on telomere length, and interprets results and relevant patient’s anamnesis to recommend the most appropriate formulas and advice to delay the effect of cellular aging in adult male and female population.

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