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Countstar® BioMed is a professional counter in the field of cell therapy, is applicable to cells with diameters ranging from 2-180μm, and realizes an accurate and reliable counting of cells commonly seen in clinical treatment such as lymphocytes, dendritic cells and other stem cells. In addition, the data management system in line with FDA requirements greatly meets the QC needs in clinical examination. The output of standard clinical standard data reports provides great convenience for the storage and management of user data.

Data Management System Meeting the Requirements of the FDA and the GMP

Central data management and multi-level permission settings are realized;

Central monitoring and management of measured data nationwide is possible with one equipment code specific to each measurement;

Non-modifiable measurements ensures output of real data;

The database supports sustainable management, and data can be traced through the sample No., operator and cell parameters;

Test reports meeting clinical requirements can be output in one of many formats;

Establish a nationwide unified cell quality control system meeting the requirements of FDA and GMP 

Stability: CV in measurements of different counters is less than 5%;

Accuracy: CV in measurements of a single counter is less than 5%;

Countstar® BioMed  also provides verification and relevant certification documents;

Countstar® BioMed  adopts a unique fixed-focus design to reduce artificial and subjective error;

Countstar® BioMed is equipped with a data management system meeting FDA and GMP requirements;