FDA.reportPublic FDA data

iQ200

Primary DI
10837461001317
Brand
iQ200
Company
BECKMAN COULTER IRELAND INC.
Model
Select/Elite Pro (NA)
Catalog number
700-3347/700-3375
Device description
"""iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)""""iQ200 Elite 2008 Tested; 800-3052 iQ®200 Elite Pro (NA); 800-3049 IRICELL 2000 Pro (NA)"""
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQOAutomated Urinalysis System
LKMCounter, Urine Particle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQOAutomated Urinalysis SystemClinical Chemistry1
LKMCounter, Urine ParticleHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022774000IQ 200 SYSTEMIntl. Remote Imaging Systems2002-10-21LKM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10837461001317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1083746100131710837461001317

GMDN Terms#

Term, Definition table
TermDefinition
Urine analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
Device count
1
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-04-16
00854080008612SciteckSciteck Diagnostics, Inc.KQO2026-04-07
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.KQO2025-09-18
04987486005292Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
00015482117344AUTION™ Sticks 9EB - Test StripsARKRAY USA, INC.KQO2024-12-02
00015482181550AUTION EYE™ Sheath Solution - 10L BottleARKRAY USA, INC.KQO2024-12-02
00015482181574AUTION EYE™ Control Solution H/LARKRAY USA, INC.KQO2024-12-02
00015482181598AUTION EYE™ Calibrator Focus/CalibratorARKRAY USA, INC.KQO2024-12-02
00015482188627AUTION EYE™ AI-4510 AnalyzerARKRAY USA, INC.LKM2024-12-02
14987486005299Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSKQO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-05