Genedrive® CYP2C19 ID Kit

Trade name

Genedrive® CYP2C19 ID Kit

05060654860547

506065486ID-CYP2C19-0197

Reference / catalog number

ID-CYP2C19-10-DE

GS1

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

10

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0106030101CYP 450 - INDIVIDUAL TEST

5 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not use past indicated date

  Expired kits must not be used.

• Contains biological material of animal origin

  Contains substance of animal origin

• Do not use if package is damaged

  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.

• Do not re-use

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