Stool Collection Kit (SCK-CRC)

Primary DI

08437023437070

Basic UDI-DI Code

8437023437SCKAT

Reference

SCK-04-CRC-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. like to RAID-CRC, RAID-Dx and TestUrGut test. 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, -Shipping package category (UN3373). -Analysis (instructions) form for posterior analysis of faecal microbiota.

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).