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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

EntericBio® Dx — IVDD — General IVDD by Serosep Limited

MD Atlas
Serosep Limited

EUDAMED last updated this device on Jul 8, 2022

EntericBio® Dx

B-05391513879210

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Serosep Limited
UDI-DI code: 05391513879210
Reference / catalog number: EBGPDx

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Manufacturer information

Organization name: Serosep Limited
SRN: IE-MF-000020322
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: EntericBio® Dx
UDI-DI code: 05391513879210
Basic UDI-DI: B-05391513879210
Reference / catalog number: EBGPDx
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: For in vitro diagnostic use. The EntericBio® Dx assay is a semi-automated, three-well molecular diagnostic test for direct, qualitative detection of nucleic acids from Salmonella enterica spp., Shigella spp., Campylobacter jejuni/coli/lari, Yersinia enterocolitica spp., Vibrio cholerae/parahaemolyticus, Shiga-like toxin-producing E. coli (STEC, also known as Verotoxin-producing E. coli, VTEC) stx1/stx2, Cryptosporidium parvum/ hominis, Giardia lamblia and Entamoeba histolytica in human stool samples. The assay is intended for use with liquid/loose stool samples from symptomatic patients with suspected acute gastroenteritis of bacterial or parasitic origin. The EntericBio® Dx assay can be used in combination with the optional UgenTec FastFinder software using the EntericBio® Dx plug-in for the analysis and results interpretation of the EntericBio® Dx assay PCR raw data results generated on the Roche LightCycler® 480 II PCR instrument.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105070504GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.