Fully Automated Urine Cell Analyzer UF-1000i UF WAM


Product Overview

Fully Automated Urine Cell Analyzer UF
Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software - UF-1000i with UF WAM


Device Description

An 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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: LKM

Device Name: Counter, Urine Particle

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.5200

Third Party Flag: Y

Medical Specialty: HE


Device Identifiers

Device Id: 00664369000639

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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