UF-Fluorocell SF is used to mark formed elements in urine or in body fluids for determination of red blood cells, casts, etc. counts with the Sysmex fully automated urine particle analyzers. UF-Fluorocell SF is intended for use only in conjunction with Sysmex diluent UF-CELLPACK SF.


Product Overview

UF
UF-Fluorocell SF - CE919553


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: 29 Milliliter
    • Total Volume: 29 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GJH

    Device Name: Stain, Reticulocyte

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: HE

    Review Code: N/A

    Technical Method: Y

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 864.1850

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 84987562433953

    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: 04987562433957

    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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