Cell Isolator V2

Primary DI
08800021900172
Brand
Cell Isolator V2
Company
Cytogen, Inc.
Model
CIS060
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKHApparatus, Automated Blood Cell Diluting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKHApparatus, Automated Blood Cell DilutingHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800021900172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800021900172088000219001728800021900172

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel immunoassay analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple chemical and/or biological markers in a clinical specimen. The analyser typically includes sample processing, requires analyte specific test kits or reagents, and incorporates multiple channels using two or more immunological methods which may include chromatographic or electrochemical separation, together with enzyme, fluorescent, chemiluminescent, nephelometric, radiometric, electrometric and/or photometric detection systems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827052213923hjjeong@cytogenlab.com

Regulatory Flags#

DUNS number
688482626
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800021900011Smart Biopsy™ IF StainerCST0302023-05-15
08800021900028Smart Biopsy™ Isolation KitCIKW102023-05-15
08800021900035Smart Biopsy™ Cell IsolatorCIS0302023-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800204900005CTCeptorCTCELLS, Inc.GKH2025-03-19
08800204900012CTR-SCTCELLS, Inc.GKH2025-03-19
08800204900029CTCDCTCELLS, Inc.GKH2025-03-19
08800021900028Smart Biopsy™ Isolation KitCytogen, Inc.GKH2023-05-15
08800021900035Smart Biopsy™ Cell IsolatorCytogen, Inc.GKH2023-05-08
08885016030003ClearCell® FX1 UnitBIOLIDICS LIMITEDGKH2022-09-24