RF (Rheumatoid Factor) 2 x 100 tests


Product Overview

RF (Rheumatoid Factor) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORP.® RF RGT. KIT BL-629 - BL629


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 an enzyme immunoassay (EIA) method.


Environmental Conditions

  • Special Storage Condition, Specify
    • Reagent is stable on board a clinical analyzer for 30 days
  • Special Storage Condition, Specify
    • Reagent is stable when stored at 2-8° C until expiration date
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 25 Milliliter
  • Total Volume: 6 Milliliter
    • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
    • Total Volume: 25 Milliliter
    • Total Volume: 6 Milliliter


    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: 00817302020984

    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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