FDA.reportPublic FDA data

Fully Automated Urine Particle Analyzer UF-5000

Primary DI
04987562440139
Brand
Fully Automated Urine Particle Analyzer UF-5000
Company
SYSMEX CORPORATION
Model
BN344411
Device description
Fully Automated Urine Particle Analyzer UF-5000
Published
2018-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKMCOUNTER, URINE PARTICLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKMCounter, Urine ParticleHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171883000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171883000Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.2018-04-23LKM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987562440139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987562440139049875624401394987562440139

GMDN Terms#

Term, Definition table
TermDefinition
Flow cytometry analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690664461
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620BR142626BR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660CK978289CK9782892016-08-05
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04987562518630Automated Blood Coagulation Analyzer CN-6000AX801645CV3397632025-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10837461001256iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461001300iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461001317iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461001355iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461002192iQ®200 IRIS INTERNATIONAL, INC.LKM2016-09-07
04987562408542Fully Automated Urine Particle Analyzer UF-1000iSYSMEX CORPORATIONLKM2016-08-04
00664369000639Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM SoftwareSysmex America, Inc.LKM2016-08-04