Latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum.


Product Overview

Latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum.
RF - RF1436


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using a nephelometry/turbidimetry method.


Environmental Conditions

  • Special Storage Condition, Specify
    • Do not freeze any of the reagents
  • 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: 05055273205022

    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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