UF-CELLPACK CR is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell CR. UF-CELLPACK CR is used to mark formed elements in urine (or in body fluid (cerebrospinal fluid, etc.)) for determination of nucleated specimens (white blood cells, epithelial cells and bacteria, etc.).


Product Overview

UF
UF-CELLPACK CR - CB505392


Device Description

A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 35.00
    • 2.00

  • Device Sizes

  • Total Volume: 2.1 Liter
    • Total Volume: 2.1 Liter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GIF

    Device Name: Diluent, Blood Cell

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 864.8200

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 84987562433946

    Device Type: Unit of Use

    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


    Device Id: 04987562433940

    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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