FDA.reportPublic FDA data

CTR-S

Primary DI
08800204900012
Brand
CTR-S
Company
CTCELLS, Inc.
Model
CTUK-CSP103
Published
2025-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800204900012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800204900012088002049000128800204900012

GMDN Terms#

Term, Definition table
TermDefinition
Cell centrifugation/density gradient separation reagent IVDA substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963366615
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800204900005CTCeptorCTM-C3132025-03-19
08800204900029CTCDCTUD-C1032025-03-19

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
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