Immunoassay Detection (Lateral Flow)
Rapid lateral flow immunoassay devices for professional laboratory and point-of-care settings — 75 devices in total, covering 13 clinical series.
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. 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.
Series in this method group
| Series | Devices | Details |
|---|---|---|
| Maternal & Women's Health | 5 | View list |
| Hepatitis | 2 | View list |
| Transfusion-transmitted infections | 1 | View list |
| Sexually transmitted infections | 6 | View list |
| Tropical diseases | 7 | View list |
| Gastrointestinal diseases | 10 | View list |
| Respiratory diseases | 8 | View list |
| Tumour markers | 3 | View list |
| Inflammation markers | 7 | View list |
| Cardiac markers | 5 | View list |
| Coagulation | 6 | View list |
| Drug of abuse screening | 9 | View list |
| Other tests | 6 | View list |
| Total | 75 | rapid lateral flow immunoassay devices |
How to read these pages
- Each series page lists device names exactly as they appear in the Notified Body confirmation letter, with the Basic UDI-DI and the IVDR risk class of each device.
- Intended use, sample types, performance characteristics and specifications are stated per device in the Instructions for Use (IFU) and the applicable conformity documentation.
- Packaging configurations, kit sizes and shelf life are confirmed per device in the sales contract.
For professional in-vitro diagnostic use only. Products are subject to regulatory approval and registration requirements in each market; no absolute or comparative performance claims are made on this website.
The content of this website is provided for corporate and product information purposes only. It does not constitute an offer, quotation, warranty or medical advice. The terms of the executed sales contract shall prevail.