FDA.reportPublic FDA data

UF ll CALIBRATOR

Primary DI
04987562408535
Brand
UF ll CALIBRATOR
Company
SYSMEX CORPORATION
Model
06404310
Device description
UF ll CALIBRATOR
Published
2017-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
04987562408535PrimaryGS10
84987562408531Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987562408535049875624085354987562408535
8498756240853184987562408531

GMDN Terms#

Term, Definition table
TermDefinition
Urine sediment IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(888)879-7639crc@sysmex.com

Regulatory Flags#

DUNS number
690664461
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987562516797CA CAL S014-1271-42024-02-22
04987562205936CA CAL S014127142017-10-06
00664369000899LYSERCELL WDF IICY754019ZA9000142026-04-24
04987562408528UF II CONTROL064041152022-11-30
04987562499700Automated Blood Coagulation Analyzer CN-3000CL971029CL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000BN343315CL9710292025-12-19
14987562460264EIGHTCHECK-3WP140-3004-02016-08-05
14987562460387RANGE CHECK X lll2189812016-08-05
14987562460608plt-CHECK200-4004-02017-10-06
14987562460615plt-CHECK200-4004-12017-10-06
04987562518654Automated Blood Coagulation Analyzer CS-5100CU624138BY9907572024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500AG528355BV9817982024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620CM217273BR1426262024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660CA174898CK9782892024-02-22
04987562425426Automated Blood Coagulation Analyzer CS-5100BY990757BY9907572016-08-05
04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620BR142626BR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660CK978289CK9782892016-08-05
04987562433735Automated Blood Coagulation Analyzer CS-2500BV981798BV9817982016-09-16
04987562499687Automated Blood Coagulation Analyzer CN-6000CV339763CV3397632025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000AX801645CV3397632025-08-22

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