EBV/GP/100

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 17 countries total.

Trade name

not provided

UDI-DI code

08594161958451

Basic UDI-DI

859569630001Q3

Reference / catalog number

EBV/GP/100

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. EBV is implicated in a number of diseases, including infectious mononucleosis, Burkitt's lymphoma, Hodgkin's lymphoma, stomach cancer, nasopharyngeal carcinoma, multiple sclerosis and lymphomatoid granulomatosis. Direct evidence of EBV DNA (PCR) is used primarily in the diagnosis of lymphoproliferative diseases in immunodeficient patients, chronic active EBV infections, neurological complications associated with EB viral infection, and in monitoring response to treatment. The kit is an in vitro nucleic acid amplification test intended for quantification and detection of Epstein-Barr Virus (EBV; Human herpesvirus 4) in the following clinical specimens: CSF, plasma, whole blood and BAL. The 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, aid to diagnosis or 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.

• W0105040403EBV - NA REAGENTS

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