EurobioPlex BK virus / JC virus

Organization name

Eurobio Scientific

SRN

FR-MF-000011745

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 2 countries total.

Trade name

EurobioPlex BK virus / JC virus

UDI-DI code

D-EBX-028QN

Basic UDI-DI

B-EBX-028QN

Reference / catalog number

EBX-028

Issuing entity

EUDAMED

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 EurobioPlex BK virus/JC virus test uses real-time polymerase chain reaction (PCR) amplification and is designed for the qualitative detection of these viruses from a DNA nucleic acid extract. The test allows diagnosis of presumptive viral infections in primary infection or reactivation, or to complete a proven or undetermined diagnosis. Extracted DNA is the starting material for the EurobioPlex BK virus / JC virus kit. The EBX-028 reference is designed to perform 96 reactions.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

D-EBX-028QN

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• W0105070502OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS