SCK-04-DX-es

Organization name

GOODGUT, SLU

SRN

ES-MF-000000229

Manufacturer status

Active

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08437023437087

Basic UDI-DI

8437023437SCKAT

Reference / catalog number

SCK-04-DX-es

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

1

Additional product description

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. Target population 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 analyses 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W05019001FAECES COLLECTION DEVICES

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• Expiration date
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