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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

iSolutions™ Enteric Bacteria & C.… — IVDD — General IVDD

MD Atlas
ID SOLUTIONS

EUDAMED last updated this device on Aug 18, 2023

iSolutions™ Enteric Bacteria & C. difficile Fullplex qPCR

B-03760367181251

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ID SOLUTIONS
UDI-DI code: 03760367181251
Reference / catalog number: IS-ENTBAC-CD-100 (FR) - Boîtes

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Manufacturer information

Organization name: ID SOLUTIONS
SRN: FR-MF-000024876
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: iSolutions™ Enteric Bacteria & C. difficile Fullplex qPCR
UDI-DI code: 03760367181251
Basic UDI-DI: B-03760367181251
Reference / catalog number: IS-ENTBAC-CD-100 (FR) - Boîtes
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: Test basé sur la technologie de la PCR en temps réel (ou qPCR) pour la détection qualitative des ADN de Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio fluvialis, Plesiomonas shigelloides, Aeromonas spp et Clostridium difficile, bactéries responsables de maladies diarrhéiques.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105070201GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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Software identification

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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.