HPVS/GP/100

Organization name

GeneProof a.s.

SRN

CZ-MF-000002370

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 16 countries total.

Trade name

not provided

UDI-DI code

08594161958307

Basic UDI-DI

B-08594161958307

Reference / catalog number

HPVS/GP/100

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The kit is an in vitro nucleic acid amplification test intended for detection of Human Papillomavirus in the clinical specimen: swab. The 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 qualitative detection. The kit is intended for diagnostics, aid to diagnosis and screening. It is designed for professional use in laboratories with trained staff. The intended testing population is sexually active individuals. The target population is the EU population.

Additional information URL

https://www.geneproof.com/products

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105041003PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS