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.
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 ⧉.
New versions of the IFU for rBGA are now available (release 2025/05).
EN ISO 13485:2016, issued July 08th, 2025
Certificate Directive 98/79/EC, issued May 20th, 2022
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 ⧉.
![]() | 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 |
![]() | 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 |
![]() | 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 |
![]() | English (EN) | Version 24, RUO | valid for all batches | Release: 2025/05 |
![]() | German (DE) | Version 24, RUO | valid for all batches | Release: 2025/05 |
![]() | 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.