A58433

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 2 countries total.

Trade name

not provided

UDI-DI code

08595696304409

Basic UDI-DI

859569630005QB

Reference / catalog number

A58433

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. HHV-6/HHV-7 primary infection is the cause of the common childhood illness exanthema subitum. Diseases linked to HHV-6 reactivation are many including autoimmune, cancer, cancer-related or organ diseases. Active HHV-6 infection may cause development of more than one of the illnesses concurrently. HHV-7 infection can lead to or is associated with a number of other symptoms, including acute febrile respiratory disease, fever, rash, vomiting, diarrhoea, low lymphocyte counts, and febrile seizures. The GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit is an in vitro nucleic acid amplification test intended for quantification and detection of Human Herpesvirus 6 (HHV-6) and Human Herpesvirus 7 (HHV-7) by real-time polymerase chain reaction (PCR) method. The clinical specimens used for detection are whole blood, plasma, CSF. The GeneProof Human Herpesvirus 6/7 (HHV-6/7) 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-6 and HHV-7. The kit is intended for diagnostics, an aid to diagnosis and monitoring and it is designed for professional use in laboratories with trained staff.

Additional information URL

https://thermofisher.com/geneproofIFU

Clinical sizes

No clinical sizes registered for this device.

• W0105040524HHV-6,7,8 - NA REAGENTS

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