The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.

The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
ChloroChek® Chloridometer® Sweat Chloride Analyzer - Model 3400

A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of chloride in a clinical specimen (e.g., sweat, urine, serum or other body fluids) using a coulometric titration. Typically, a constant current is applied to the introduced sample to reduce chloride ions that are present in the solution and the magnitude and duration of the current prior to reaching the endpoint is used to determine the chloride concentration in relation to a reference solution. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JFS

Device Name: Coulometric, 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

Device Id: 03661540304088

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