FDA.reportPublic FDA data

CS triCHROME CD45-FITC/MsIgG1-RD1/MsIgG1-PC5

Primary DI
15099590540395
Brand
CS triCHROME CD45-FITC/MsIgG1-RD1/MsIgG1-PC5
Company
Beckman Coulter, Inc.
Model
6607019
Catalog number
6607019
Device description
CYTO-STAT triCHROME CD45-FITC/MsIgG1-RD1/MsIgG1-PC5
Published
2016-09-23
Public version status
Update
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
15099590540395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959054039515099590540395

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16
15099590806422ACCESS anti-HAV CALIBRATORD258322026-01-16
15099590806439ACCESS anti-HAV QCD258332026-01-16
15099590799717MicroScanV5.03D238242025-12-17
15099590799724MicroScanV5.03D238252025-12-17
15099590799755MicroScanV5.03D238282025-12-17
15099590799762MicroScanV5.03D238292025-12-17
05099590798973MicroScanD18443D184432025-12-08
05099590798980MicroScanD18444D184442025-12-08
05099590798997MicroScanD184452025-12-08
05099590799000MicroScanD184462025-12-08
05099590799017MicroScanD184472025-12-08
05099590799024MicroScanD184482025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08

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
00850063751216CitoCBC CartridgeCYTOCHIP 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