Leukocyte deformability IVD, kit, rapid microfluidic cytometry

Definition
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.
GUDID devices
11
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860001900514Cytovale DiluentCytovale IncCV-DIL-0012025-07-03
00860001900521Cytovale CleanseCytovale IncCV-CLS-0012025-07-03
00860001900507Cytovale Reagent KitCytovale IncCV-REA-1012025-07-03
00860001900538IntelliSep Quality Control KitCytovale IncCV-ICL-0012025-07-03
00860001900583Cytovale Sample Preparation ModuleCytovale IncCV-SPM-0012025-07-03
00860001900590Cytovale Cell Imaging ModuleCytovale IncCV-CIM-0012025-07-03
00860005204601Cytovale Imaging Analysis ModuleCytovale IncCV-IAM-0012025-07-03
00860005204618Cytovale Reagent KitCytovale IncCV-REA-0012025-07-03
00860005204625IntelliSep CartridgeCytovale IncCV-ICG-0012025-07-03
00860005204656Cytovale DiluentCytovale IncCV-DIL-0012025-07-03
00860005204663Cytovale CleanseCytovale IncCV-CLS-0012025-07-03