Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers


Product Overview

Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
N FLC Standard SL - 10482440


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DFH

    Device Name: Kappa, Antigen, Antiserum, Control

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: IM

    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: 866.5550

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00842768031441

    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


    Device Id: 04056869221946

    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


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