8844342-13

Organization name

Genome Diagnostics B.V.

SRN

NL-MF-000000453

Manufacturer status

Active

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• CW010

  Consult instructions for use before use

Primary placement in Netherlands; available across 32 countries total.

Trade name

not provided

UDI-DI code

D-8844342-13AY

Basic UDI-DI

B-8844342-13AY

Reference / catalog number

8844342-13

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Chimerism Monitoring Workflow is a product family consisting of non-automated, quantitative, in-vitro diagnostic assays intended to genotype both recipient and donor(s) before transplantation, and subsequently determine a chimeric status over time by means of qPCR. The specimen is human genomic DNA. The Chimerism Monitoring Workflow consists of: • KMRtype to determine informative markers for recipient and donor(s) by multiplexed genotyping. • KMRtrack to determine a chimeric status with recipient and/or donor(s) informative markers. • KMRassay containing the necessary buffer, enzyme and reference assay for the performance of KMRtype and KMRtrack. The Chimerism Monitoring Workflow is intended for in vitro diagnostic use by professional health care personnel, such as laboratory technicians and physicians, trained in chimerism analysis and qPCR technique in diagnostic laboratories.

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

D-8844342-13AY

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• W010699GENETIC TESTS - OTHER