7004

Organization name

4bases SA

SRN

CH-MF-000042125

Manufacturer status

Active

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

76404133800972

Basic UDI-DI

764041338700X3V

Reference / catalog number

7004

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The UDI Primer Set is an accessory intended for use with in vitro diagnostic (IVD) systems employing hybrid capture-based next-generation sequencing (NGS) library preparation workflows for Illumina and Oxford Nanopore sequencing platforms.  The device consists of a set of primers containing unique dual index (UDI) barcode sequences used during library preparation to enable the identification of individual samples during sequencing.  The indexes are incorporated into DNA fragments during a pre-capture amplification. The combination of these indexes allows the unique identification of samples and supports multiplex sequencing, enabling multiple samples to be processed within the same sequencing run. The device does not perform any diagnostic analysis and does not generate clinical or diagnostic results.

Additional information URL

https://cloud.4bases.ch/

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.

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER