Clinical flow cytometry -
diagnostic and QC reagents 
for cell manufacturing

Reproducibility of flow cytometric data strongly depends on the reagents used for staining. Therefore, reagent quality is of key concern in clinical flow cytometry. Regulatory requirements add another dimension of specifications to reagents used for clinical workflows. It is therefore mandatory that in vitro diagnostic reagents are designed and manufactured according to standardized conditions found in the medical devices standard EN ISO 13485. 

For complete regulatory notes click here.

Product categories

Analyte-specific reagents (ASRs)

Optimized active ingredients for laboratory developed tests

Show all Clinical flow cytometry products

Further information

Background information

MACSQuantify™ 21 CFR Part 11 option for data submission to the FDA
Background information

Find more information on our certified quality management system
Product highlight

Standardized flow cytometric analysis with the CD19 CAR T Cell Express Mode Package
Product highlight

MACSQuant® Analyzer 10, the ideal instrument for IPC/QC

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