HHV8/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 13 countries total.

Trade name

not provided

UDI-DI code

08595696300180

Basic UDI-DI

859569630006QD

Reference / catalog number

HHV8/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. Primary HHV-8 infection may be associated with fever and a maculopapular rash. HHV-8 is the etiologic agent of Kaposi's sarcoma, primary effusion lymphoma, and multicentric Castleman's disease. These cancers often occur in the context of immunosuppression, which has caused development of HHV8-associated malignancies. The GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit is an in vitro nucleic acid amplification test for quantification and detection of Human Herpesvirus 8 (HHV-8) by real-time polymerase chain reaction (PCR) method. The clinical specimens used for detection are CSF, plasma, saliva and whole blood. The GeneProof Human Herpesvirus 8 (HHV-8) 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 for HHV-8. 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.

• W0105040524HHV-6,7,8 - NA REAGENTS

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