Home GUDID 00860005204618 Cytovale Reagent Kit
Primary DI 00860005204618
Brand Cytovale Reagent Kit
Company Cytovale Inc
Model CV-REA-001
Catalog number CV-REA-001
Device description Cytovale Reagent Kit used to prepare the leukocyte suspension for analysis in the IntelliSep test by the Cytovale System. The two components in the Cytovale Reagent Kit: Reagent A (lysis solution w/
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 false 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 00860005204670 Package GS1 6 In Commercial Distribution 00860005204618 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 00860005204670 00860005204670 860005204670 0860005204670 00860005204618 00860005204618 860005204618 0860005204618
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 false 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 00860005204625 IntelliSep Cartridge CV-ICG-001 CV-ICG-001 2025-07-03
Other Devices Sharing Product Codes# 
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