The ChloroChek Chloridometer Reagent Set is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration when used with the ChlorChek Chloridometer.
ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS - SS-248
Device Description
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.
Environmental Conditions
- 45.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 Identifiers
Device Id: 03661540304095
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
