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.

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Miltenyi Biotec Inc.
phone: +1 800 FOR MACS
fax: + 1 530 745 2806
macs@miltenyibiotec.com