Organization name

Yourgene Health UK Ltd

SRN

GB-MF-000024810

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

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• Consult instructions for use

Primary placement in France; available across 26 countries total.

Trade name

Yourgene® QST*R Base

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05060402680076

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

506040268ANM3

Reference / catalog number

AN0PLB2

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Yourgene® QST*R Base is an in vitro medical device intended to be used by healthcare professionals for the quantitative detection of viable autosomal trisomies: trisomy 13, trisomy 18 and trisomy 21, and sex chromosome status. The device is intended to be used with DNA extracted from either amniotic fluid (AF) or chorionic villus samples (CVS). This is a manual test intended to screen pregnant women who have been assessed as being at risk of carrying a fetus with one of the detected aneuploidies. The device is not intended to be used in isolation for screening, monitoring, risk assessment, or prognosis. The device is for professional use only within a molecular or cytogenetics laboratory environment. Yourgene QST*R Base is available as a 50-test kit. The resulting data is to be analysed using GeneMapper (version 5.0 or onwards, or version 6.0 onwards if using SeqStudio), or GeneMarker (version 2.6.3 or onwards). Configuration files compatible with this software are available from Yourgene Health. The test is intended to be used in conjunction with other diagnostic procedures to support or discount the proposed clinical diagnosis. The test is for Professional Use only within a molecular or cytogenetics laboratory environment.

Additional information URL

https://yourgenehealth.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0106010306MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS

• IVDR Class C medical devices in EUDAMED