Stool Collection Kit (SCK-TUG)

Primary DI

08437023437100

Basic UDI-DI Code

8437023437SCKAT

Reference

SCK-04-TUG-es

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

GOODGUT, SLU

The Stool Collection Kit is a non-sterile class A, rule 5 (c) collection kit for stool samples to be used with the other in vitro Medical Devices for diagnostic developed in GoodGut. It is composed of: -Universal container of polypropylene aseptically produced with spoon CE IVD self-certified, -Disposable nitrile glove powder free CE self-certified, -Toilet paper for stool sampling, -Protection bag for biological substances category B (UN3373), -Instructions for use detailing the sample collection (labeling packaging and instruction form), -Shipping package category (UN3373). -Analysis (instructions) form for posterior analysis of faecal microbiota. The target population of the Stool Collection Kit will be subjects who, through prescription of a specialist medical doctor or by its own, will require one of the analysis of the GoodGut’s medical devices, and need to collect and send the stool sample appropriately. Its use is domestic as it is intended to be used directly by the user at home, without the help of any qualified professional.

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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