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Cytovale Cell Imaging Module

The Cell Imaging Module (CIM) of the Cytovale System, used to directly image leukocytes under test for the IntelliSep test. Part of the Cytovale System.

Details

Device typeLeukocyte 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.

FDA categoryDeformability Cytometry For Sepsis Risk Assessment

Device ID00860001900590

Catalog numberCV-CIM-001

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone415-417-2188

Emailsupport@cytovale.com

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