Gastrointestinal Diseases
Rapid lateral flow immunoassay devices for gastrointestinal diseases. This series covers 10 devices listed in the Notified Body confirmation letter — 10 Class B.
EU regulatory status
165 devices listed in the Notified Body confirmation letter (TÜV Rheinland, NB 0197, 2026-07-10) under Regulation (EU) 2024/1860 — transition to 2028-12-31 (Class C) / 2029-12-31 (Class B).
The confirmation letter records the IVDR application and the signed written agreement, and sets out the transitional arrangements under Regulation (EU) 2024/1860. It is not an IVDR certificate, a CE certificate or an EU Declaration of Conformity, and it does not exempt any device from the remaining conformity assessment steps.
Devices in this series (names as listed in the confirmation letter)
| # | Device name | Basic UDI-DI | IVDR class |
|---|---|---|---|
| 1 | H.Pylori Ab Test Kit | 697994388Ir03035 | Class B |
| 2 | H.Pylori Ag Test Kit | 697994388Ir03137 | Class B |
| 3 | Rotavirus Ag Test Kit | 697994388Ir0343D | Class B |
| 4 | Adenovirus/Rotavirus Ag Test Panel | 697994388Ir0353F | Class B |
| 5 | FOB Fecal Occult Blood Test Kit | 697994388Ir0373K | Class B |
| 6 | TF Transferrin Test Kit | 697994388Ir0383M | Class B |
| 7 | FOB/TF Test Panel | 697994388Ir0393P | Class B |
| 8 | Norovirus GI/GII Antigen Detection Kit | 697994388Ir04038 | Class B |
| 9 | Calprotectin (Calp) Detection Kit | 697994388Ir0413A | Class B |
| 10 | Clostridium Difficile Related Test Kit | 697994388Ir0423C | Class B |
Device names are reproduced verbatim from the Notified Body confirmation letter (Table 2). Basic UDI-DIs are the identifiers registered for these devices.
Intended use, performance and specifications
Intended use, sample types, performance characteristics and specifications are as stated in the Instructions for Use (IFU) and the applicable conformity documentation for each device. Device specifications and availability are subject to regulatory approval in each market. No absolute or comparative performance claims are made on this website.
For professional in-vitro diagnostic use only.