iDNA PGx CNS kit

Primary DI

D-5200423500223L4

Basic UDI-DI Code

B-5200423500223L4

Reference

Ref.002

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 PGX CNS is an in vitro diagnostic medical device that provides supplementary (non-deterministic) genetic information regarding drug metabolism, effectiveness, side effects, or dosage of specific CNS medications. The oral swab is collected by the user using specialized oral swab collection kits. Once the sample is collected, it is sent to the manufacturer, iDNA Laboratories, for analysis. The personalized pharmacogenetic reports describe whether an individual has alleles associated with altered metabolism of certain drugs and provide interpretative information regarding the potential interaction of the identified phenotype with the following medications: amisulpride, amitriptyline, aripiprazole, carbamazepine, citalopram, clobazam, clomipramine, clozapine, diazepam, duloxetine, escitalopram, fluoxetine, fluvoxamine, haloperidol, lamotrigine, mirtazapine, olanzapine, paliperidone, paroxetine, phenytoin, quetiapine, risperidone, sertraline, topiramate, valproic acid, venlafaxine, ziprasidone, donepezil, galantamine and vortioxetine.

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