FDA.reportPublic FDA data

Smart Biopsy™ Cell Isolator

Primary DI
08800021900035
Brand
Smart Biopsy™ Cell Isolator
Company
Cytogen, Inc.
Model
CIS030
Published
2023-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800021900035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800021900035088000219000358800021900035

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell diluterA mains electricity (AC-powered), automated or semi-automated device, typically used in the laboratory, to make appropriate dilutions of a blood sample for further analysis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827052213923cgkim@cytogenlab.com
+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
08800021900172Cell Isolator V2CIS0602026-03-06
08800021900011Smart Biopsy™ IF StainerCST0302023-05-15
08800021900028Smart Biopsy™ Isolation KitCIKW102023-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800021900172Cell Isolator V2Cytogen, Inc.GKH2026-03-06
08800204900005CTCeptorCTCELLS, Inc.GKH2025-03-19
08800204900012CTR-SCTCELLS, Inc.GKH2025-03-19
08800204900029CTCDCTCELLS, Inc.GKH2025-03-19
08800021900028Smart Biopsy™ Isolation KitCytogen, Inc.GKH2023-05-15
08885016030003ClearCell® FX1 UnitBIOLIDICS LIMITEDGKH2022-09-24