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DaraEx and Mezagitamab
We are pleased to announce the publication of a new study ⧉ highlighting the effectiveness of DaraEx in overcoming interference caused by mezagitamab during serological pre-transfusion testing.
T Cell Staining Reagent available now
DaraEx plus
A recent publication details the use of imusyn's IVD DaraEx plus to mitigate the interference of anti-CD38 antibodies in the IAT ⧉.
DaraEx plus is available from inno-train ⧉.
imuPep Class I Peptide Binding Analysis
New IFU Versions
New versions of the IFU for rBGA are now available (release 2025/05).
Certificate Available for Download
EN ISO 13485:2016, issued July 08th, 2025
Certificate Directive 98/79/EC, issued May 20th, 2022
Certificates
 | ISO 13485:2016 Certificate | Expiry date: 2026-05-22 |
| Directive 98/79/EC Certificate | Expiry date: 2025-05-26* |
*Please note:
As of August 16th, 2022 imusyn has withdrawn the recombinant Blood Group Antigen (rBGA) Reagents from the scope of EC Certificate 0197/HL1381718-1. Our rBGA are available for Research Use Only (RUO).
The EC certificate cannot be extended. imusyn has received a Confirmation Letter in accordance with Regulation (EU) 2024/1860. This letter was issued on May 22, 2025, by TÜV Rheinland LGA Products GmbH, a Notified Body designated under Regulation (EU) 2017/746 (IVDR) and identified by number 0197 in the NANDO database.
The transition timelines applicable to the devices covered by this letter - provided imusyn continues to meet the other conditions outlined in Article 110(3c) of the IVDR, as amended by Regulation (EU) 2024/1860 - are as follows: December 31, 2027.