Home GUDID 00860001900590 Cytovale Cell Imaging Module
Primary DI 00860001900590
Brand Cytovale Cell Imaging Module
Company Cytovale Inc
Model CV-CIM-001
Catalog number CV-CIM-001
Device description The Cell Imaging Module (CIM) of the Cytovale System, used to directly image leukocytes under test for the IntelliSep test. Part of the Cytovale System.
Published 2025-07-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QUT Deformability Cytometry For Sepsis Risk Assessment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QUT Deformability Cytometry For Sepsis Risk Assessment Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860001900590 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860001900590 00860001900590 860001900590 0860001900590
GMDN Terms# Term, Definition table Term Definition Leukocyte deformability IVD, kit, rapid microfluidic cytometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of the deformability of leukocytes in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid microfluidic cytometry method. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the early diagnosis of sepsis. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 830 millibar 1013 millibar Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 18 Degrees Celsius 28 Degrees Celsius Storage Environment Atmospheric Pressure 830 millibar 1013 millibar Storage Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 18 Degrees Celsius 28 Degrees Celsius
Regulatory Flags# DUNS number 078418950 Device count 1 Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860001900514 Cytovale Diluent CV-DIL-001 CV-DIL-001 2025-07-03 00860001900521 Cytovale Cleanse CV-CLS-001 CV-CLS-001 2025-07-03 00860001900507 Cytovale Reagent Kit CV-REA-101 CV-REA-101 2025-07-03 00860005204656 Cytovale Diluent CV-DIL-001 CV-DIL-001 2025-07-03 00860005204663 Cytovale Cleanse CV-CLS-001 CV-CLS-001 2025-07-03 00860001900538 IntelliSep Quality Control Kit CV-ICL-001 CV-ICL-001 2025-07-03 00860001900583 Cytovale Sample Preparation Module CV-SPM-001 CV-SPM-001 2025-07-03 00860005204601 Cytovale Imaging Analysis Module CV-IAM-001 CV-IAM-001 2025-07-03 00860005204618 Cytovale Reagent Kit CV-REA-001 CV-REA-001 2025-07-03 00860005204625 IntelliSep Cartridge CV-ICG-001 CV-ICG-001 2025-07-03
Other Devices Sharing Product Codes# 
cytovale.com