JCV/GP/025

Organization name

GeneProof a.s.

SRN

CZ-MF-000002370

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 9 countries total.

Trade name

not provided

UDI-DI code

08594161959281

Basic UDI-DI

859569630028QP

Reference / catalog number

JCV/GP/025

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The intended purpose of the device is related to the medical context and clinical conditions under which the device may be used. JCV infection is involved in the development of progressive multifocal leukoencephalopathy (PML) in patients with underlying immunosuppressive conditions, including Hodgkin’s lymphoma, lymphoproliferative diseases, in those undergoing antineoplastic therapy and AIDS. JCV can ultimately be implicated in severe cerebellar atrophy, mediate encephalopathy, ureteric stenosis in renal transplant recipients. The device may be used for JCV detection taking into account the contraindications connected with drugs associated with reactivation of JC virus. The GeneProof JC Virus (JCV) PCR Kit is an in vitro nucleic acid amplification test intended for quantification and detection of JC Virus (JCV) by real-time polymerase chain reaction (PCR) method. The clinical specimens used for detection are CSF, plasma, urine and whole blood. The GeneProof JC Virus (JCV) PCR Kit can be used in combination with a manual or automated extraction system. The kit is designed for human in vitro diagnostics and provides both qualitative and quantitative detection. The kit is intended for diagnostics, an aid to diagnosis and for monitoring and it is designed for professional use in laboratories with trained staff.

Additional information URL

https://www.geneproof.com/ifu

Clinical sizes

No clinical sizes registered for this device.

• W0105040523JC VIRUS - NA REAGENTS

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