Home GUDID 00860005204625 IntelliSep Cartridge
Primary DI 00860005204625
Brand IntelliSep Cartridge
Company Cytovale Inc
Model CV-ICG-001
Catalog number CV-ICG-001
Device description IntelliSep Cartridge for use by the Cytovale Cell Imaging Module, part of the Cytovale System instrument. The cartridge provides a pathway for testing of each prepared blood sample. One cartridge is used for each test performed.
Published 2025-07-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use 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 00860005204632 Package GS1 48 In Commercial Distribution 00860005204687 Package GS1 96 In Commercial Distribution 00860005204625 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 00860005204632 00860005204632 860005204632 0860005204632 00860005204687 00860005204687 860005204687 0860005204687 00860005204625 00860005204625 860005204625 0860005204625
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 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 Lot or batch true Serial number true Expiration date on label 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 00860001900590 Cytovale Cell Imaging Module CV-CIM-001 CV-CIM-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
Other Devices Sharing Product Codes# 
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