Clinical flow cytometry -
instruments and reagents 
for cell manufacturing

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

For complete regulatory notes click here.

Clinical flow cytometry portfolio

FDA-compliant data aquisition

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

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