A58428

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

08595696304355

Basic UDI-DI

859569630009QK

Reference / catalog number

A58428

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. CMV is implicated in infectious mononucleosis. CMV implicated diseases can present in many ways including fever, pneumonia, pneumonitis, colitis, hepatitis, myocarditis, esophagitis, gastrointestinal ulcerations, diarrhoea, retinitis, visual impairment, blindness, polyradiculopathy, transverse myelitis, encephalopathy, encephalitis, seizures, and coma. Congenital CMV infections can result in non-specific symptoms and include rhinitis, pharyngitis, myalgia, arthralgia, headache and fatigue. The GeneProof Cytomegalovirus (CMV) PCR Kit is an in vitro nucleic acid amplification test intended for quantification and detection of Cytomegalovirus (CMV; Human beta herpesvirus 5) by real-time polymerase chain reaction (PCR) method. The clinical specimens used for detection are CSF, plasma, serum, urine, whole blood. The GeneProof Cytomegalovirus (CMV) 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://thermofisher.com/geneproofIFU

Clinical sizes

No clinical sizes registered for this device.

• W0105040205CMV - NA REAGENTS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification