FDA.reportPublic FDA data

CitoCBC Cartridge

Primary DI
00850063751216
Brand
CitoCBC Cartridge
Company
CYTOCHIP INC
Model
1210
Device description
The CitoCBC Cartridge is intended for use on the CitoCBC Analyzer to perform complete blood count (CBC) test.
Published
2025-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GKZCounter, Differential Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063751216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063751216008500637512168500637512160850063751216

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081107751
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063751117CitoCBC Analyzer11102025-07-01
00850063751315CitoCBC Control13102025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414289694Atellica HEMA 580 Analyzer (SMS ready)Siemens Healthcare Diagnostics Inc.GKZ2026-02-06
03610230009932ABX Micros 60HORIBA ABX SASGKZ2026-01-23
00380740213565AlinityABBOTT LABORATORIESGKZ2025-12-25
00850063751117CitoCBC AnalyzerCYTOCHIP INCGKZ2025-07-01
04987562508440XQ-520 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2025-01-14
03610230009444Yumizen H2500HORIBA ABX SASGKZ2024-11-29
03610230009451Yumizen H2500HORIBA ABX SASGKZ2024-11-29
15099590762889Stem-Kit ReagentsBeckman Coulter, Inc.GKZ2024-10-25
15099590762896StemTrol Control CellsBeckman Coulter, Inc.GKZ2024-10-25
07290016991086HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2024-09-02
04987562503131XQ-320 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2024-05-24
00380740138851AlinityAbbott LaboratoriesGKZ2023-11-16
00382906643438BD Trucount™BECTON, DICKINSON AND COMPANYGKZ2023-08-07
00382906654212FACSDivaBECTON, DICKINSON AND COMPANYGKZ2022-10-12
00860008385840Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385864Athelas HomeAthelas, Inc.GKZ2022-07-29
17290016991076HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19
08809317540993ADAMNanoEnTek, Inc.GKZ2021-02-15
08809317541006ADAMNanoEnTek, Inc.GKZ2021-02-15
08809317540627ADAMNanoEnTek, Inc.GKZ2020-09-02
08809317540634ADAMNanoEnTek, Inc.GKZ2020-09-02
15099590671242DxH 500BECKMAN COULTER IRELAND INC.GKZ2020-08-31
15099590729110UniCel DxH 690T Coulter Cellular Analysis System Beckman Coulter, Inc.GKZ2020-08-31
00630414237909ADVIA 2120i Refurb w/o AutosamplerSiemens Healthcare Diagnostics Inc.GKZ2020-07-06
00382906642868BD FACSDiva™BECTON, DICKINSON AND COMPANYGKZ2020-05-05
00382906643452BD FACSDiva™BECTON, DICKINSON AND COMPANYGKZ2020-05-05
00382906641106BD FACSCanto™BECTON, DICKINSON AND COMPANYGKZ2020-04-08
00382906641120BD FACSCanto™BECTON, DICKINSON AND COMPANYGKZ2020-04-08
00382906641144BD FACSCanto™BECTON, DICKINSON AND COMPANYGKZ2020-04-08
00382906641182BD FACSDiva™BECTON, DICKINSON AND COMPANYGKZ2020-04-08