B19/ISEX/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 14 countries total.

Trade name

not provided

UDI-DI code

08594161957652

Basic UDI-DI

B-08594161957652

Reference / catalog number

B19/ISEX/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 quantitative and qualitative detection of parvovirus B19 from clinical specimens: plasma, whole blood. The 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 and aid to diagnosis and it is designed for professional use in laboratories with trained staff. The intended testing population are immunocompromised patients, pregnant women and fetuses, symptomatic individuals with exanthem erythema infectiosum (Fifth Disease). 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.

• W0105040509PARVOVIRUS B 19 - NA REAGENTS