3007

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

76404133800422

Basic UDI-DI

764041338300X2Z

Reference / catalog number

3007

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 Index Set is an accessory intended for use with in vitro diagnostic (IVD) systems employing amplicon-based next-generation sequencing (NGS) library preparation workflows for Illumina sequencing. The device consists of a set of indexing primers containing unique barcode sequences (indexes) used during library preparation to enable the identification of individual samples during sequencing. The indexes are incorporated into amplified DNA fragments during an indexing PCR step, in which pools are extended by DNA polymerase adding indexes at the end of the DNA fragments during amplification and become part of the resulting DNA library molecules. 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.

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