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 Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated Chloride coulometric titration analyser IVD, semi-automated

• Primary Device ID: 03661540304095
• NIH Device Record Key: 90d8859e-6c9e-4441-847f-56f5780a0423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS
• Version Model Number: SS-248
• Company DUNS: 052423787
• Company Name: ELITECHGROUP INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540304095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121823

FDA Product Code

• JFS: Coulometric, Chloride

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-01
• Device Publish Date: 2021-02-19

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