AccessGUDID - DEVICE: ChloroChek® Chloridometer® Sweat Chloride Analyzer (03661540304088)

GUDID

Device Identifier (DI) Information

Brand Name: ChloroChek® Chloridometer® Sweat Chloride Analyzer
Version or Model: Model 3400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540304088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60045	Chloride coulometric titration analyser IVD, semi-automated	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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JFS	Coulometric, Chloride

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121823	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 352969af-174c-4906-b6f8-b4a4d988de45
Public Version Date: February 23, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016