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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
Instructions for Use and Safety Data Sheets
Instructions for Use (IFU) and Safety Data Sheets (SDS) for imusyn's products DaraEx plus, DaraEx, rBGA, Dyemer, and myDyemer. To open .pdf files, you may need a PDF reader, e.g. freely available from Adobe ⧉.
Instructions for Use (IFU)
DaraEx plus (IVD)
 | Czech (CS) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Dansk (DA) | Version 10.1, CE | valid for all batches | Release: 2025/05/26 |
| English (EN) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Finnish (FI) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| French (FR) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| German (DE) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Greek (EL) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Hungarian (HU) | Version 10.1, CE | valid for all batches | Release: 2025/03/13 |
| Italian (IT) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Norwegian (NB) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Romanian (RO) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Slovak (SK) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Spanish (ES) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
| Swedish (SV) | Version 10.1, CE | valid for all batches | Release: 2024/07/02 |
DaraEx plus (IVD acc. IVDR)
| English (EN) | Version A001.1, CE | valid for batches with the expiry date YYYY-MM or later | Release: 2025/MM/DD |
| German (DE) | Version A001.1, CE | valid for batches with the expiry date YYYY-MM or later | Release: 2025/06/16 |
DaraEx (RUO)
| English (EN) | Version 22, RUO | valid for DaraEx with purple lids only | Release: 2024/07/01 |
| German (DE) | Version 22, RUO | valid for DaraEx with purple lids only | Release: 2024/07/01 |
rBGA (RUO)
| English (EN) | Version 24, RUO | valid for all batches | Release: 2025/05 |
| German (DE) | Version 24, RUO | valid for all batches | Release: 2025/05 |
Dyemer & myDyemer (RUO)
| English (EN) | Version 2.0, RUO | valid for all batches | Release: 2024/06 |
IVD = In Vitro Diagnostic Medical Device. RUO = Research Use Only.
If you require a paper copy of an IFU, please contact us by phone or via our contact form, quoting your fax number.
For older versions of the IFUs, please contact us via our contact form.