RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems.


Product Overview

RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems.
RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor - 10309082


Device Description

An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 5.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CGZ

    Device Name: Electrode, Ion-Specific, Chloride

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    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: 862.1170

    Third Party Flag: Y

    Medical Specialty: CH


    Code: CEM

    Device Name: Electrode, Ion Specific, Potassium

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    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: 862.1600

    Third Party Flag: Y

    Medical Specialty: CH


    Code: JGS

    Device Name: Electrode, Ion Specific, Sodium

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    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: 862.1665

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00630414452289

    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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