Clinical flow cytometry

CE-IVD reagents for clinical flow cytometry

  • CE-IVD quality grade for manufacturing according to quality management system ISO 13485
  • Fulfilling essential regulatory requirements for In-Vitro Diagnostic Medical Devices (Directive 98/79/EC)
  • Optimized for quality control of cellular products in translational workflows

The reliability and reproducibility of flow cytometric data is strongly influenced by the performance of the antibody conjugates used for staining. This is why reagent quality is key not only in research but even more so in clinical flow cytometry. Regulatory requirements associated with clinical workflows add another dimension of specifications to the reagent. For the development of diagnostic protocols, it is mandatory that in vitro diagnostic antibodies are manufactured according to the medical devices standard EN ISO 13485. Additionally, the reagent provider has to declare the conformity of the reagents with the requirements of the European Union In-Vitro Diagnostic Medical Devices Directive 98/79/EC.

To extend reliability and reproducibility of flow cytometric data we now offer our 7-AAD Staining Solution and Red Blood Cell Lysis Solution (10x) in CE-IVD quality. Our 7-AAD Staining Solution is a ready-to-use reagent suitable for the evaluation of cell viability in mono- or multiparametric analyses of human peripheral blood using flow cytometry. The Red Blood Cell Lysis Solution (10x)  has been developed for optimal lysis of red blood cells from human peripheral blood for in vitro diagnostic use in flow cytometry.

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Miltenyi Biotec Inc.
phone: +1 800 FOR MACS
fax: + 1 530 745 2806