KF290832

Organization name

Immundiagnostik AG

SRN

DE-MF-000020905

Manufacturer status

Active

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• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04050598010833

Basic UDI-DI

B-04050598010833

Reference / catalog number

KF290832

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

The MutaGENE Cystic Fibrosis Real-Time PCR Kit is a molecular biology assay for the examination of the F508del mutation in the Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) from genomic DNA derived from human blood samples. The examined variation is connected to the development of severe symptoms of Cystic Fibrosis (Mucoviscidosis). The assay is an in vitro diagnostic medical device and intended to be used by professional users in a laboratory environment. It can be performed manually or using an automated platform. The assay serves as an aid in diagnosis of cystic fibrosis in patients with suspected cystic fibrosis or an increased risk of developing the disease.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0106010101CYSTIC FIBROSIS

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• Expiration date
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