FDA.reportPublic FDA data

N/A

Primary DI
00382903445639
Brand
N/A
Company
Becton, Dickinson And Company
Model
344563
Catalog number
344563
Device description
Stem Cell Enumeration Kit 50 Tests
Published
2016-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKZCounter, differential cell
OYEFlow cytometric reagents and accessories.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2
OYEFlow Cytometric Reagents And Accessories.Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK110037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK110037000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382903445639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382903445639003829034456393829034456390382903445639

GMDN Terms#

Term, Definition table
TermDefinition
White blood cell count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)232-8995BDBCustomerService@bd.com

Regulatory Flags#

DUNS number
119218200
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403523512HemoSphere AltaHEMA70CC2HEMA70CC22026-09-18
00885403523536HemoSphere AltaHEMAPSC200HEMAPSC2002026-09-18
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKBB64EKBB2026-09-18
00885403533146TruWave Reusable Cable64EKGE164EKGE12026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKGE264EKGE22026-09-18
00885403533160TruWave Reusable Cable64EKH64EKH2026-09-18
00885403533610TruWave Reusable Cable70ANHS70ANHS2026-09-18
00885403533634Pressure Slave Cable70ANS70ANS2026-09-18
00885403533641Cable COO Catheter Interface70CC270CC22026-09-18
00885403533665TruWave Reusable CablePX15S162PX15S1622026-09-18
00885403533764Smart Pressure ControllerPC1QPC1Q2026-09-18
00885403533771Smart Pressure Controller Accessory KitPC1QAKPC1QAK2026-09-18
00885403543282TruWave Reusable CablePX12S162PX12S1622026-09-18
00885403543299TruWavePX17S162PX17S1622026-09-18
00885403543305TruWavePX21S162PX21S1622026-09-18
00885403543312TruWavePX6D162PX6D1622026-09-18
00885403543428TruWavePX6T162PX6T1622026-09-18
00885403543435TruWavePX2D162PX2D1622026-09-18
00885403543459TruWavePX11T162PX11T1622026-09-18
00885403543466TruWavePX7D162PX7D1622026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)Beckman Coulter, Inc.GKZ2026-05-19
00860008385888WBC Test StripAthelas, Inc.GKZ2026-04-28
00860008385871Athelas HomeAthelas, Inc.GKZ2026-04-27
00630414289694Atellica HEMA 580 Analyzer (SMS ready)Siemens Healthcare Diagnostics Inc.GKZ2026-02-06
03610230009932ABX Micros 60HORIBA ABX SASGKZ2026-01-23
00380740213565AlinityABBOTT LABORATORIESGKZ2025-12-25
15099590754013DxFLEXBeckman Coulter, Inc.OYE2025-09-02
00850063751117CitoCBC AnalyzerCYTOCHIP INCGKZ2025-07-01
00850063751216CitoCBC CartridgeCYTOCHIP INCGKZ2025-07-01
06944904002422BC-3200 Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.GKZ2025-01-17
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
00382906657329BD FACSuiteBecton, Dickinson And CompanyOYE2024-01-09
00380740138851AlinityABBOTT LABORATORIESGKZ2023-11-16
00382906643438BD Trucount™Becton, Dickinson And CompanyGKZ2023-08-07
00382906642363FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642370FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642356FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906635181FACSLyricBecton, Dickinson And CompanyOYE2022-10-12
00382906654212FACSDivaBecton, Dickinson And CompanyGKZ2022-10-12
00382906654212FACSDivaBecton, Dickinson And CompanyOYE2022-10-12
00382906631282BD FACSDuetBecton, Dickinson And CompanyOYE2022-08-23
20860008385868Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385840Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385864Athelas HomeAthelas, Inc.GKZ2022-07-29