Clinical flow cytometry
Diagnostic and quality-control reagents for cell manufacturing
- Quality reagents for reproducible flow cytometric data in clinical settings
- Designed and manufactured according to ISO 13485 standards
- Compliant with GMP guidelines
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.