FDA.reportPublic FDA data

COULTER Latron

Primary DI
15099590250690
Brand
COULTER Latron
Company
Beckman Coulter, Inc.
Model
7546915
Catalog number
7546915
Device description
COULTER LATRON Primer
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GKLCounter, Cell, Automated (Particle Counter)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKLCounter, Cell, Automated (Particle Counter)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962988000COULTER GEN-S SYSTEMCoulter Corp.1996-10-30GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590250690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959025069015099590250690

GMDN Terms#

Term, Definition table
TermDefinition
Non-blood cell primer/calibrator/control material IVD, reagentA substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00858604006108IVOSHAMILTON THORNE, INC.GKL2019-11-30
00858604006719CEROSHAMILTON THORNE, INC.GKL2019-11-30
00630414222882ADVIA® 120/2120/2120i CBC TIMEpacSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222899ADVIA 120/2120/2120i® DIFF TIMEpacSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222905ADVIA 120/2120/2120i® autoRETICSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222912ADVIA 120/2120/2120i® AUTOreticSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222929ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222943ADVIA 120/2120/2120i® DefoamerSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222950ADVIA 120/2120/2120i® CN-FREE CBC TIMEPACSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414223032ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414224305ADVIA 120/2120/2120i® OPTIpointSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414224329ADVIA 120/2120/2120i® OPTIpointSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414473383ADVIA 120/2120/2120i® Perox SheathSiemens Healthcare Diagnostics Inc.GKL2016-09-24
10816068020174Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL PolypropyleneAdvanced Instruments, LLCGKL2016-09-23
10816068020211Advanced Instruments GloCyte® Red Blood Cell Test Reagent KitAdvanced Instruments, LLCGKL2016-09-23
10816068020228Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent KitAdvanced Instruments, LLCGKL2016-09-23
10816068020204Advanced Instruments GloCyte® Test Cartridge & Tray - 25 CartridgesAdvanced Instruments, LLCGKL2016-09-23
15099590233754COULTER Latron CP-XBeckman Coulter, Inc.GKL2016-09-23
15099590250683COULTER LatronBeckman Coulter, Inc.GKL2016-09-23
20816068020201Advanced Instruments GloCyte® Test Cartridge Kit - 8 TraysAdvanced Instruments, LLCGKL2016-09-23
00816068020009Advanced Instruments GloCyte® Pipette, 30µL Fixed VolumeAdvanced Instruments, LLCGKL2016-09-23
00816068020016Advanced Instruments GloCyte® Pipette, 10µL Fixed VolumeAdvanced Instruments, LLCGKL2016-09-23
00816068020139Advanced Instruments GloCyte® Automated Cell Counter SystemAdvanced Instruments, LLCGKL2016-09-23
00816068020146Advanced Instruments GloCyte® Instrument AssemblyAdvanced Instruments, LLCGKL2016-09-23
00816068020153Advanced Instruments GloCyte® Vacuum Preparation Station AssemblyAdvanced Instruments, LLCGKL2016-09-23
00816068020245Advanced Instruments GloCyte® Count Template CartridgeAdvanced Instruments, LLCGKL2016-09-23
10837461002475iQ®200 BECKMAN COULTER IRELAND INC.GKL2016-09-07
04987562402021Automated Hematology Analyzer pocH-100iSYSMEX CORPORATIONGKL2016-08-04
04987562429219Automated Hematology Analyzer XP series XP-300SYSMEX CORPORATIONGKL2016-08-04