Organization name

Genome Diagnostics B.V.

SRN

NL-MF-000000453

Manufacturer status

Active

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• Consult instructions for use

  Consult instructions for use before use

Primary placement in Netherlands; available across 32 countries total.

Trade name

NGSgo®-AmpX v2 HLA-DQA1

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.

08718469369355

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.

871846936ngsgo-ampxv2F4

Reference / catalog number

7970862

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

NGSgo-AmpX v2 is a qualitative in vitro diagnostic kit, intended for the amplification of the following genes in human genomic DNA specimens: • HLA Class I: HLA-A, HLA-B, HLA-C • HLA Class II: HLA-DRB1, HLA-DRB3, HLA-DRB4, HLA-DRB5, HLA DQA1, HLA DQB1, HLA-DPA1, HLA-DPB1 The kit is intended to generate HLA amplicons by PCR (polymerase chain reaction), which are suitable for HLA genotyping at high-resolution level. The generated amplicons can be used as input for downstream Next-Generation Sequencing (NGS) applications. It is a single-use, non-automated assay to aid in the diagnosis of HLA gene compatibility between donor and recipient for transplantation purposes (e.g. hematopoietic stem cell transplantation). The intended testing population are both, transplant donors as well as transplant recipients. NGSgo-AmpX v2 is intended for laboratory professional use in an EFI or ASHI accredited diagnostic laboratory setting, by personnel trained in PCR amplification. It is intended to be used for transplantation procedures where time is not a critical factor.

Additional information URL

https://www.gendx.com/ifu2/

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.

• W01030499TISSUE TYPING REAGENTS - OTHER

• IVDR Class C medical devices in EUDAMED

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