REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
Basic Information
- Primary DI
- 08809317540610
- Basic UDI-DI Code
- B-08809317540610
- Reference
- ADAM2 & CD34K-025
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- NanoEntek, Inc.
Additional Description
The ADAMII is a medical device which is designed for counting of stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients. 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010199 | REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER |
| W0202010101 | AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).