FDA.reportPublic FDA data

Cellmek

Primary DI
15099590750312
Brand
Cellmek
Company
Beckman Coulter, Inc.
Model
C44603
Device description
Cellmek SPS
Published
2025-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590750312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959075031215099590750312

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVDAn electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906663405BD FACSDuetBecton, Dickinson And CompanyPER2023-06-12
04987562501908Sample Preparation System PS-10SYSMEX CORPORATIONPER2022-11-30
00382906631282BD FACSDuetBecton, Dickinson And CompanyPER2022-08-23
00382906641144FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906641168FACSBecton, Dickinson And CompanyPER2020-04-08
00382906641199FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906641229FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906577658FACSBecton, Dickinson And CompanyPER2019-02-13
15099590563547TQ-Prep WorkstationBeckman Coulter, Inc.PER2016-09-23
15099590638191PrepPlus 2Beckman Coulter, Inc.PER2016-09-23
00382906466006BD FACSCanto™BECTON, DICKINSON AND COMPANYPER2016-06-08
00382906466020BD FACSCanto™BECTON, DICKINSON AND COMPANYPER2016-06-08
00382906472052FACSBecton, Dickinson And CompanyPER2016-06-08