The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.


Product Overview

The C
C-Reactive Protein HS ELISA - EIA-3954


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a fluorescent immunoassay method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.


Environmental Conditions

No Data Available


Device Sizes

  • Stop Solution
  • TMB
  • Total Volume: 50 Milliliter
  • Sample Diluent
  • Total Volume: 12 Milliliter
  • Total Volume: 1 Milliliter
  • Standards
  • Total Volume: 11 Milliliter
  • Conjugate Reagent
    • Stop Solution
    • TMB
    • Total Volume: 50 Milliliter
    • Sample Diluent
    • Total Volume: 12 Milliliter
    • Total Volume: 1 Milliliter
    • Standards
    • Total Volume: 11 Milliliter
    • Conjugate Reagent


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DCK

    Device Name: C-Reactive Protein, Antigen, Antiserum, And 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: 866.5270

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00840239039545

    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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