iDNA Cardio Health kit

Primary DI

D-052004235002165R

Basic UDI-DI Code

B-052004235002165R

Reference

Ref. 005

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ

The iDNA Cardio Health kit is an in vitro diagnostic product that evaluates genetic analysis using interpretative software from an oral swab sample. By combining genetic data with phenotypic and clinical characteristics, it determines an individual's personalized risk for cardiovascular diseases, including: coronary artery disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, heart failure, arrhythmia – atrial fibrillation, ischemic stroke. The assessment is based on the Polygenic Risk Score (PRS) and the Adjusted Polygenic Risk Score (APRS). The kit aims at the early prevention of cardiovascular diseases, serving as a consultative guide to reduce or eliminate risk factors. The results are presented in a detailed report format.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).