FDA.reportPublic FDA data

ClearCell® FX1 Unit

Primary DI
08885016030003
Brand
ClearCell® FX1 Unit
Company
BIOLIDICS LIMITED
Model
CBB-F011001-C
Published
2022-09-24
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
08885016030003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885016030003088850160300038885016030003

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

Regulatory Flags#

DUNS number
595253935
Device count
1
Premarket exempt
true
Serial number
true

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
08800021900035Smart Biopsy™ Cell IsolatorCytogen, Inc.GKH2023-05-08