FDA.reportPublic FDA data

iQ®200

Primary DI
10837461002147
Brand
iQ®200
Company
BECKMAN COULTER IRELAND INC.
Model
iQ® Calibrator
Catalog number
800-3103
Device description
iQ® Calibrator Pack
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
JJWUrinalysis Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJWUrinalysis Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10837461002147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1083746100214710837461002147

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
Device count
1
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751582Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751605Maintenance AgentUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751612SG ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751629Color ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751636Turbidity ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751643SG CalibratorUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751650Turbidity CalibratorUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751667Mutiple Control for SGUrit Medical Electronic Co., Ltd.JJW2026-06-26
50885380126091CARDINAL HEALTHCardinal Health 200, LLCJJW2026-06-10
50885380126107CARDINAL HEALTHCardinal Health 200, LLCJJW2026-06-10
06935740750653Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750677Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750721Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-04-16
00682607200672Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200689Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200696Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200702Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
20682607200676Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200683Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200690Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200706Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)QUANTIMETRIX CORPORATIONJJW2023-05-04