FDA.reportPublic FDA data

iQ®200

Primary DI
10837461002475
Brand
iQ®200
Company
BECKMAN COULTER IRELAND INC.
Model
Body Fluids Module
Catalog number
800-3704
Device description
iQ®200 Body Fluids Module (CD only)
Published
2016-09-07
Public version status
Update
Distribution status
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
K050235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050235000IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.2005-03-23GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10837461002475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1083746100247510837461002475

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
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
15099590695743iChemVELOCITYB793192026-04-27
15099590225889AQUIOS CL B301662016-09-23
15099590677466Navios EX10 Color 3 lasersB809102017-07-06
15099590682996Navios EX8 Color 2 lasersB809112017-07-06
15099590683009Navios EX6 Color 2 lasersB809122017-07-06
15099590683245Navios EXACQUISITION NEW USER SOFTWARE V2.0 WIN 7B91237 2017-07-06
15099590683252Navios EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 B91238 2017-07-06
15099590683269Navios EXOFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7 B912392017-07-06
15099590683276Navios EXTETRA SOFTWARE V2.0 NEW USER B91240 2017-07-06
15099590671242DxH 500B40601B406012020-08-31
15099590679781DxH 520B406022019-03-22
10837461001065Iris660-3021660-30212025-04-16
10837461002321Iris800-3215800-32152025-04-16
15099590694968ClearLLab 10CB900022019-04-05
15099590694975ClearLLab 10CB900032019-03-26
15099590694982ClearLLab 10CB998832019-03-26
15099590701475ClearLLab 10CB968052019-03-26
15099590701482ClearLLab 10CB968062019-03-26
15099590701499ClearLLab 10CB968072019-03-26
15099590701505ClearLLab 10CB968082019-03-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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15099590250690COULTER Latron Beckman 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
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