ADAMII-CD34 Kit

Primary DI

08809317540634

Basic UDI-DI Code

B-08809317540634

Reference

CD34K-025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

NanoEntek, Inc.

The ADAMII CD34 System includes the ADAMII-CD34 Kit which is designed for use with the ADAMII instrument, a benchtop image-basede fluoresence cell counter. The ADAMII CD34 System provides an enumeration of viable CD34+ cells/μL, viable CD45+ cells/μL, and calculates viable % CD34+ of viable CD45+ for the following fresh samples: mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA, hematopoietic progenitor cell - apheresis (HPC-A) collected in ACD or ACD+ Heparin, and fresh/frozen cord blood collected in PCD. The ADAMII CD34 System is intended for use in clinical laboratories and for in vitro diagnostic use only. It is not intended for use in point-of-care settings.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).