Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

Trade name

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

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.

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06950996004541

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.

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B-06950996004541

Reference / catalog number

N7001B

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.

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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.

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IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

This kit is used for in vitro quantitative detection for copy number of exon 7 of survival motor neuron 1 (SMN1) and exon 7 of survival motor neuron 2 (SMN2) in human EDTA anticoagulated whole blood specimen, dried blood spot specimen, oropharyngeal swab and saliva. The test results are only used for the purpose of auxiliary diagnosis of Spinal Muscular Atrophy (SMA), and should be comprehensively considered in conjunction with the patient's clinical diagnosis and other laboratory tests.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Please refer to the IFU.

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