The EU Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), aims to protect the human health and the environment by limiting the use of certain hazardous substances in products, produced or sold within the EU. Their complex specifications must be implemented step by step by companies.
Immundiagnostik placed great emphasis on product compliance and the environment early on in the selection of its suppliers.
In preparation for the implementation of the requirements regarding "REACH: Inclusion of Alkylphenol Ethoxylates in Annex XIV" we would like to inform you about the general changes.
Please note that this information refers to changes in product information and product labeling for professional use in the laboratory.
Product performance evaluation, test principle, test performance and evaluation of results are not affected by the change made.
Changes in product information and product labeling:
Change of surfactant in WASHBUF (wash buffer concentrate, 10x):
After the change of the surfactant, the labels of the primary packaging feature the hazard pictogram "exclamation mark" (GHS07).
The corresponding hazard and safety information is described in the Instructions for use in section "12. PRECAUTIONS":
The wash buffer concentrate (10x) with the new alternate surfactant will be continued under the same article number (K 0001.C.100). For the products, performance and intended use remain identical.
Traceability during the changeover to an alternative surfactant is ensured via the batch number.
For the following products, an adaptation of the automation protocol may be necessary:
- Albumin ELISA (K 6330)
- DAO ELISAs (K 8500 and K 8510)
- ß-Defensin 2 ELISA (K 6500)
- EDN ELISA (K 6821)
- IDKmonitor Adalimumab total ADA ELISA (K 9651)
- IDKmonitor Infliximab total ADA ELISA (K 9654)
- IDKmonitor Vedolizumab drug level ELISA (K 9658)
- Pankreatische Elastase ELISA (K 6915)
- MPO ELISA (K 6630)
- sIgA ELISA (K 8880)
- TNF-alpha ELISA (K 9610)
If you need to adapt the test protocol on your IVD automation platform, please contact our technical support.
If you have any questions, please contact your sales representative and/or international sales contact person.