RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer


Product Overview

RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer
RAPIDPOINT® 350 Sensor Module - 10375812


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.


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: 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


    Code: JFP

    Device Name: Electrode, Ion Specific, Calcium

    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: 862.1145

    Third Party Flag: Y

    Medical Specialty: CH


    Code: CHL

    Device Name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

    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: 862.1120

    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: GKF

    Device Name: Instrument, Hematocrit, Automated

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HE

    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: 864.5600

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00630414566337

    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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