ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS

GUDID 03661540304095

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.

ELITECHGROUP INC.

Chloride coulometric titration analyser IVD, semi-automated
Primary Device ID03661540304095
NIH Device Record Key90d8859e-6c9e-4441-847f-56f5780a0423
Commercial Distribution StatusIn Commercial Distribution
Brand NameChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS
Version Model NumberSS-248
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540304095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JFSCoulometric, Chloride

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-01
Device Publish Date2021-02-19

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Trademark Results [ChloroChek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHLOROCHEK
CHLOROCHEK
85455986 4258927 Live/Registered
Wescor Inc.
2011-10-25

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