6001

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

76404133800590

Basic UDI-DI

764041338600X3N

Reference / catalog number

6001

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 Barcode Set is an accessory intended for use with in vitro diagnostic (IVD) systems employing amplicon-based next-generation sequencing (NGS) library preparation workflows for Ion Torrent sequencing. The device consists of a set of custom-designed barcode sequences incorporated into adapter oligonucleotides used during library preparation to enable the identification of individual samples during sequencing. The barcodes are introduced into DNA fragments through adapter ligation, whereby barcode-containing adapters are ligated to the ends of amplicons and become part of the resulting DNA library molecules. The combination of these barcodes allows the unique identification of samples and supports multiplex sequencing, enabling multiple samples to be processed within the same sequencing run. The Barcode Set provides molecular barcode sequences used during the library preparation step of the NGS workflow.

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