BKV/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 8 countries total.

Trade name

not provided

UDI-DI code

08594161959267

Basic UDI-DI

859569630027QM

Reference / catalog number

BKV/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. BK virus is implicated in a number of diseases such as haemorrhagic and non-haemorrhagic cystitis, ureteric stenosis, and nephritis. Pulmonary diseases that involve BK virus include pneumonitis and acute nonspecific upper respiratory tract infection. BK virus has also been detected in the tissue samples of a variety of neoplasms, which have predominantly been brain tumours of glial and neural origin, in autoimmune disease and rarely in primary CNS disease and/or reactivation of CNS disease. The GeneProof BK Virus (BKV) PCR Kit is an in vitro nucleic acid amplification test intended for quantification and detection of BK Virus (BKV) by real-time polymerase chain reaction (PCR) method. The clinical specimens used for detection are plasma, urine, whole blood, CSF. The GeneProof BK Virus (BKV) 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.

• W0105040522BK VIRUS - NA REAGENTS

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