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
OTC false
Sterile false
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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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