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 reagents are designed and manufactured according to the medical devices standard EN ISO 13485 and compliant with GMP practices mandated by 21 CFR 820.
To extend reliability and reproducibility of flow cytometric data we now offer our 7-AAD Staining Solution in ASR quality. It 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.
For complete regulatory notes click here