IntelliSep Cartridge

Basic Information

• Brand Name: IntelliSep Cartridge
• Primary DI: 00860005204625
• Version / Model: CV-ICG-001
• Catalog Number: CV-ICG-001
• Company Name: Cytovale Inc
• Labeler DUNS: 078418950
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-03
• Public Version: 1
• Public Version Date: 2025-07-11
• Public Version Status: New
• Public Device Record Key: 51d9f2f0-0d15-4e9a-96da-de68ff613dac

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QUT	Deformability Cytometry For Sepsis Risk Assessment	Microbiology	866.3215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67567	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860005204625	GS1
Package	00860005204632	GS1	Qty 48 in carton	48	In Commercial Distribution
Package	00860005204687	GS1	Qty 96 in carton	96	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius