IVD GENERAL USE CONSUMABLE DEVICES - OTHER

Primary DI

05391513879104

Basic UDI-DI Code

0539151387SPS7Z

Reference

EBSPSA-v2

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Serosep Limited

The EntericBio® Stool Preparation Solution (SPS) is a buffer solution used to resuspend the stool sample before inoculation into EntericBio® assay test well. The resuspended sample is then placed on the EntericBio® heatstation and heated at 103°C for 30 min to release the DNA. The heat-treated samples are placed on the EntericBio® workstation for fully automated transfer of the processed samples directly to the lyophilised reaction wells. EntericBio® SPS is only approved for use with the EntericBio® kits, which are a series of qualitative molecular diagnostic tests detecting bacterial, parasitic or viral pathogens to aid in the diagnosis of infectious gastroenteritis or gastrointestinal nosocomial infections.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).