EurobioPlex Community-acquired bacterial meningitis

Organization name

Eurobio Scientific

SRN

FR-MF-000011745

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 France; available across 1 country total.

Trade name

EurobioPlex Community-acquired bacterial meningitis

UDI-DI code

D-EBX-020-09BE

Basic UDI-DI

B-EBX-020-09BE

Reference / catalog number

EBX-020-09

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 Community-acquired bacterial meningitis device (EBX-020) is a test uses real-time polymerase chain reaction (PCR) amplification, and is designed for the qualitative detection from cerebrospinal fluid (CSF) of the three most frequently involved bacteria in the etiology of Community-acquired Bacterial Meningitis (MBcom): Neisseria meningitidis (meningococcus), Streptococcus pneumoniae (pneumococcus), and Haemophilus influenzae. Real-time PCR can be carried out directly on CSF without extraction, which can answer the need of diagnostic urgency in this pathology, but also on extracted DNA. This test is indicated to confirm a diagnosis of presumption of infection in patients or complete a proven or indeterminate diagnosis by other techniques (clinical diagnosis with semiological examination, bacteriological study and culture of CSF). The EBX-020-09 reference is designed to perform 9 reactions.

Additional information URL

https://www.eurobio-scientific.com/fr/produit/eurobioplex-meningite-bacterienne-acquise-dans-la-communaute/

Clinical sizes

No clinical sizes registered for this device.

• W0105070505MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS

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