Home GUDID 08800021900028 Smart Biopsy™ Isolation Kit
Primary DI 08800021900028
Brand Smart Biopsy™ Isolation Kit
Company Cytogen, Inc.
Model CIKW10
Published 2023-05-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name GKH Apparatus, Automated Blood Cell Diluting
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GKH Apparatus, Automated Blood Cell Diluting Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800021900028 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800021900028 08800021900028 8800021900028
GMDN Terms# Term, Definition table Term Definition Red blood cell separation reagent A substance or reactant intended to be used for the isolation of red blood cells (RBCs) from a whole blood clinical specimen by promoting aggregation of RBCs. It is primarily used in a blood bank or transfusion centre for blood component separation (e.g., isolation of stem cells from cord blood); it may also be used to facilitate in vitro examination of specimens by way of reducing the availability of cells not relevant to the diagnostic process.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 26 Degrees Celsius
Regulatory Flags# DUNS number 688482626 Device count 1 Premarket exempt true Kit true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08800021900172 Cell Isolator V2 CIS060 2026-03-06 08800021900011 Smart Biopsy™ IF Stainer CST030 2023-05-15 08800021900035 Smart Biopsy™ Cell Isolator CIS030 2023-05-08
Other Devices Sharing Product Codes# 
cytogenlab.com