This product is intended for in vitro diagnostic use in the calibration of RF on clinical chemistry analysers.


Product Overview

This product is intended for in vitro diagnostic use in the calibration of RF on clinical chemistry analysers.
RF CAL - RF2301


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of rheumatoid factor 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: DHR

    Device Name: System, Test, Rheumatoid Factor

    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: 866.5775

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 05055273205039

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos