FDA.reportPublic FDA data

IntelliSep Quality Control Kit

Primary DI
00860001900538
Brand
IntelliSep Quality Control Kit
Company
Cytovale Inc
Model
CV-ICL-001
Catalog number
CV-ICL-001
Device description
IntelliSep Quality Control Kit, a two-level quality control kit derived from stabilized whole blood for use with the IntelliSep test on the Cytovale System.
Published
2025-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001900538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001900538008600019005388600019005380860001900538

GMDN Terms#

Term, Definition table
TermDefinition
Leukocyte deformability IVD, kit, rapid microfluidic cytometryA 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
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
415-417-2188support@cytovale.com

Regulatory Flags#

DUNS number
078418950
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001900514Cytovale DiluentCV-DIL-001CV-DIL-0012025-07-03
00860001900521Cytovale CleanseCV-CLS-001CV-CLS-0012025-07-03
00860001900507Cytovale Reagent KitCV-REA-101CV-REA-1012025-07-03
00860005204656Cytovale DiluentCV-DIL-001CV-DIL-0012025-07-03
00860005204663Cytovale CleanseCV-CLS-001CV-CLS-0012025-07-03
00860001900583Cytovale Sample Preparation ModuleCV-SPM-001CV-SPM-0012025-07-03
00860001900590Cytovale Cell Imaging ModuleCV-CIM-001CV-CIM-0012025-07-03
00860005204601Cytovale Imaging Analysis ModuleCV-IAM-001CV-IAM-0012025-07-03
00860005204618Cytovale Reagent KitCV-REA-001CV-REA-0012025-07-03
00860005204625IntelliSep CartridgeCV-ICG-001CV-ICG-0012025-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414323640Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323657Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323534Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323541Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323558Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323565Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323572Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323589Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00815762026362Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-06
00815762026508Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-04
03610230008584BFTROLHORIBA ABX SASJPK2024-09-26
03610230009581ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009598ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009604ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
00868556000215HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000239HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000246HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000253HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00815762020520R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2024-04-02
00815762020537R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2024-04-02
00815762020605R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2024-04-02
06944904031408BC-6D Hematology ControlShenzhen Mindray Bio-Medical Electronics Co., Ltd.JPK2023-10-19
06944904031422BC-RET Hematology ControlShenzhen Mindray Bio-Medical Electronics Co., Ltd.JPK2023-10-19
14987562502742XN CHECKSYSMEX CORPORATIONJPK2021-01-18
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14987562502766XN CHECKSYSMEX CORPORATIONJPK2021-01-18
00847661003182Meter TraxBIO-RAD LABORATORIES, INC.JPK2020-09-14
00847661003212Meter TraxBIO-RAD LABORATORIES, INC.JPK2020-09-14
00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity KitAdvanced Instruments, LLCJPK2020-07-21
05055273215618HAEMATOLOGY CONTROL - LEVEL 1 (HAEM CNTL - LEVEL 1)RANDOX LABORATORIES LIMITEDJPK2019-06-03