EurobioPlex Neonatal 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 4 countries total.

Trade name

EurobioPlex Neonatal bacterial meningitis

UDI-DI code

D-EBX-022-36BX

Basic UDI-DI

B-EBX-022-36BX

Reference / catalog number

EBX-022-36

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 Neonatal bacterial meningitis device (EBX-022) 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 neonatal/maternal-fetal Bacterial Meningitis (MBmf): Streptococcus agalactiae, Listeria monocytogenes and Escherichia coli. Real-time PCR can be carried out directly on non-extracted samples of CSF, 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-022-36 reference is designed to perform 36 reactions.

Additional information URL

https://www.eurobio-scientific.com/fr/produit/eurobioplex-meningite-bacterienne-non-natale/

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