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.
For complete regulatory notices click here