Basic Information
- Primary DI
- 08437023437063
- Basic UDI-DI Code
- 8437023437PLAT6F
- Reference
- PLAT-03-020600
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- GOODGUT, SLU
Additional Description
The in vitro diagnostic medical devices developed by GoodGut are tests that base their diagnoses on the detection and quantification of specific microorganisms present in stool samples. The detection and quantification of the biomarkers is done by qPCR, and, in a second step, a diagnostic is performed through the application of an algorithm where the support of a web platform is required.GoodGut-Test is a web application that complements the RAID-CRC qPCR kit, RAID-Dx qPCR kit, and TestUrGut qPCR kit. The platform is a complement (accessory) of the specific product since without it the quantitative results derived from the multiplex qPCR assays run would not be translated into a diagnostic report
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02060292 | POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).