EurobioPlex FluCoSyn

Organization name

Eurobio Scientific

SRN

FR-MF-000011745

Manufacturer status

Active

D-EBX-042-10029

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

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 9 countries total.

Trade name

EurobioPlex FluCoSyn

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

D-EBX-042-10029

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-EBX-042-10029

Reference / catalog number

EBX-042-100

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

EUDAMED

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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 FluCoSyn is a real-time reverse transcription polymerase chain reaction (RT-PCR) amplification test in an RNA nucleic acid extract designed for in vitro use for the qualitative determination of the presence or absence of the following respiratory viruses: SARS-CoV-2, an emerging virus first identified in Wuhan, China, at the end of 2019; Influenza viruses (Influenza A and B / Flu A and B); and Respiratory Syncytial Virus (RSV A and B). The test is indicated to help diagnose presumptive infection with these three viruses associ-ated with respiratory syndrome in humans, or to complement a proven or undetermined di-agnosis, specifically distinguishing the SARS-CoV-2 coronavirus from RSV or Influenza respiratory viruses. The diagnosis should always be made by medical personnel and in the clinical, historical and symptomatic context of the patient. The EBX-042-100 reference is designed to perform 100 reactions.

Additional information URL

https://www.eurobio-scientific.com/fr/produit/eurobioplex-flucosyn/

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.

• W0105040599VIROLOGY - NA REAGENTS - OTHER

• IVDD — General medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.