CRPhsWR (C-Reactive Protein high sensitivity Wide Range) 2 x 220 tests


Product Overview

CRPhsWR (C
CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W WIDE RANGE CC646 - CC646


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 spectrophotometry method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.


Environmental Conditions

  • 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

  • Total Volume: 40.5 Milliliter
  • Kit contains 2 reagent cartridges, 1 package insert and 2 user defined parameters
  • Total Volume: 21 Milliliter
    • Total Volume: 40.5 Milliliter
    • Kit contains 2 reagent cartridges, 1 package insert and 2 user defined parameters
    • Total Volume: 21 Milliliter


    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: 00817302022094

    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