STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor laser.


Product Overview

STROMATOLYSER
STROMATOLYSER-FB - 94404516


Device Description

A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 1.00

  • Device Sizes

  • Total Volume: 5 Liter
    • Total Volume: 5 Liter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GGK

    Device Name: Products, Red-Cell Lysing Products

    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: 864.8540

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 04987562022335

    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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