FDA.reportPublic FDA data

Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software

Primary DI
00664369000639
Brand
Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software
Company
Sysmex America, Inc.
Model
UF-1000i with UF WAM
Device description
Fully Automated Urine Cell Analyzer UF-1000i UF WAM
Published
2016-08-04
Public version status
Update
Distribution status
Not 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
LKMCOUNTER, URINE PARTICLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKMCounter, Urine ParticleHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080887000SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARESysmex America, Inc.2008-05-02LKM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664369000639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664369000639006643690006396643690006390664369000639

GMDN Terms#

Term, Definition table
TermDefinition
Flow cytometry analyser IVDAn electrically-powered automated or semi-automated 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.

Contacts#

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

Regulatory Flags#

DUNS number
021860424
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
00664369000752WAM (Work Area Management)5.X2025-03-14
00664369000851Caresphere Workflow Solution1.X2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00015482188627AUTION EYE™ AI-4510 AnalyzerArkray USA, Inc.LKM2024-12-02
04987562440139Fully Automated Urine Particle Analyzer UF-5000SYSMEX CORPORATIONLKM2018-05-31
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