VITROS Chemistry Products hsCRP Reagent


Product Overview

VITROS Chemistry Products hsCRP Reagent
VITROS - 6801739


Device Description

A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].


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: NQD

    Device Name: Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

    Device Class: 2

    Physical State: N/A

    Definition: In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

    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: 10758750006885

    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


    Device Id: 20758750006882

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10758750006885

    Package Quantity: 36

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


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