Stem-Trol Control Cells

Primary DI

15099590220020

Basic UDI-DI Code

150995903IM363255

Reference

IM3632

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

IMMUNOTECH SAS

Stem-Trol Control Cells is a quality control product for immunophenotyping analysis using CD45 and/or CD34 monoclonal antibodies reagents by flow cytometry. It provides a positive cell control that is processed in the same manner as a blood specimen when Stem-Trol Control Cells are spiked into a peripheral whole blood sample. This allows verification of reagent performance including the enumeration and the methods used for staining targeted cells (i.e. CD34+ Hematopoietic Progenitor Cells HPC), lysing erythrocytes, and analyzing samples with flow cytometry.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).