Organization name

Genome Diagnostics B.V.

SRN

NL-MF-000000453

Manufacturer status

Active

D-88432834G

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

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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

KMRassay qPCR buffer & Enzyme

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.

D-88432834G

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.

B-88432834G

Reference / catalog number

8843283

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.

EUDAMED

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.

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

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

• W010699GENETIC TESTS - OTHER

• IVDD — General medical devices in EUDAMED

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