EntericBio® Stool Preparation Solution

Organization name

Serosep Limited

SRN

IE-MF-000020322

Manufacturer status

Active

Primary placement in Ireland; available across 1 country total.

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

Trade name

EntericBio® Stool Preparation Solution

UDI-DI code

05391513879104

Basic UDI-DI

0539151387SPS7Z

Reference / catalog number

EBSPSA-v2

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

240

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHER

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