EntericBio Gastro Panel 2

Primary DI

05391513879142

Basic UDI-DI Code

B-05391513879142

Reference

EBGP2A-v2

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Serosep Limited

For in vitro diagnostic use. The EntericBio® Gastro Panel 2 assay is a semi-automated, two-strip molecular diagnostic test for the direct, qualitative detection of nucleic acids from Salmonella enterica spp., Shigella spp., Campylobacter jejuni / coli / lari, Shiga-like toxin-producing E. coli (STEC, also known as Verotoxin-producing E. coli, VTEC), Cryptosporidium parvum / hominis and Giardia lamblia 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® Gastro Panel 2 assay can be used in combination with the optional UgenTec FastFinder Software using the EntericBio® Gastro Panel 2 plug-in for the analysis and results interpretation of the EntericBio® Gastro Panel 2 assay PCR raw data results generated on the LightCycler® 480 II PCR instrument.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).