omnomicsNGS

Organization name

Euformatics Oy

SRN

FI-MF-000030204

Manufacturer status

Active

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• CW011

  The software must be used exclusively by qualified personnel who are trained in genetic data interpretation and have received appropriate training from Euformatics support personnel. omnomicsNGS is intended to support, not replace, expert clinical judgment The output is dependent on the quality of input data (e.g., correctly formatted VCFs with reliable annotations) The software should be kept up to date to reflect the latest medical knowledge and clinical databases Any variant classifications should be validated against current guidelines and external references where possible

Primary placement in Finland; available across 6 countries total.

Trade name

omnomicsNGS

UDI-DI code

06429811494008

Basic UDI-DI

B-06429811494008

Reference / catalog number

06429811494008

Issuing entity

GS1

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02079092VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.