Eu Ivdd Eu Ivd General On The Market 🇮🇪 Ireland

EntericBio® Viral Panel 3

Serosep Limited · 🇮🇪 Ireland
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05391513879265
Basic UDI-DI Code
B-05391513879265
Reference
EBVP3
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Serosep Limited

Additional Description

For in vitro diagnostic use. The EntericBio® Viral Panel 3 assay is a semi-automated, two strip molecular diagnostic test for direct, qualitative detection of nucleic acids from Rotavirus A, Adenovirus F40/F41, Sapovirus, Astrovirus and Norovirus (Genogroup I and Genogroup II) in human stool samples. The assay is intended for use with liquid/loose stool samples from symptomatic patients with suspected acute gastroenteritis of viral origin. The EntericBio® Viral Panel 3 assay can be used in combination with the optional UgenTec FastFinder software using the EntericBio® Viral Panel 3 plug-in for the analysis and results interpretation of the EntericBio® Viral Panel 3 assay PCR raw data results generated on the Roche LightCycler® 480 II PCR instrument.

CND Nomenclature Codes

Code Description
W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS

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