Genedrive® CYP2C19 ID Kit

Dénomination commerciale

Genedrive® CYP2C19 ID Kit

05060654860547

506065486ID-CYP2C19-0197

Numéro de référence/catalogue

ID-CYP2C19-10-DE

GS1

IVDR Classe C

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

10

Description complémentaire du produit

The Genedrive® CYP2C19 ID Kit is an automated pharmacogenetic in vitro diagnostic kit for the qualitative detection of DNA variants in the CYP2C19 gene, by fluorescent hybridisation probe-based end-point PCR. The function of the Genedrive® CYP2C19 ID Kit is to identify CYP2C19 variant alleles (*2, *3, *4, *8 *17, *35) and distinguish from the wild type CYP2C19 variant (*1), in genomic DNA, obtained from human buccal cells. The CYP2C19 gene product is the cytochrome P450 2C19 enzyme. The Genedrive® CYP2C19 ID Kit is a qualitative test which identifies individuals carrying loss of function CYP2C19 alleles *2, *3, *4, *8, *35, and the gain of function CYP2C19 allele *17, which impact activity of CYP2C19 enzyme. The Genedrive® CYP2C19 ID Kit is used in conjunction with the Genedrive® System to inform clinicians on an individual’s CYP2C19 genotype and corresponding CYP2C19 enzyme metaboliser status, as defined by CPIC guidelines. Individuals who can benefit from this test are adults over the age of 18, eligible for therapeutics that are metabolised by the CYP2C19 enzyme. Therapeutic decisions should not be made solely on the results of this test. The intended users of the Genedrive® CYP2C19 ID Kit are trained healthcare professionals, in near patient settings within a professional healthcare facility environment including hospitals and diagnostic laboratories.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0106030101CYP 450 - INDIVIDUAL TEST

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• Consulter la notice d’utilisation

  Consult instructions for use

• Ne pas utiliser après la date indiquée

  Expired kits must not be used.

• Contient une matière biologique d’origine animale

  Contains substance of animal origin

• Ne pas utiliser si l’emballage est endommagé

  If the packaging has been severely damaged, unintentionally opened or exposed to conditions outside of the acceptable storage conditions (as above) then please notify Genedrive Diagnostics Ltd., or your local distributor and do not use.

• Ne pas réutiliser

  Each kit is single use. Do not re-use.