FDA.reportPublic FDA data

CTCeptor

Primary DI
08800204900005
Brand
CTCeptor
Company
CTCELLS, Inc.
Model
CTM-C313
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
08800204900005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800204900005088002049000058800204900005

GMDN Terms#

Term, Definition table
TermDefinition
Cytological centrifuge IVDAn electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.

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
08800204900012CTR-SCTUK-CSP1032025-03-19
08800204900029CTCDCTUD-C1032025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800021900172Cell Isolator V2Cytogen, Inc.GKH2026-03-06
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