DIALISA 2MP 62003

GUDID 15060456180345

DIALISA 2MP, DS2 Automated ELISA Processing System

DYNEX TECHNOLOGIES, INC.

Multiple clinical chemistry analyser IVD, laboratory, automated

• Primary Device ID: 15060456180345
• NIH Device Record Key: 3d604ef7-9895-435f-b23b-8c624ffdb449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIALISA 2MP
• Version Model Number: 62003
• Catalog Number: 62003
• Company DUNS: 170119536
• Company Name: DYNEX TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com
• Phone: 703 631 7800
• Email: customerservice@dynex.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060456180348 [Primary]
GS1	15060456180345 [Package]; Contains: 05060456180348; Package: Carton [1 Units]; In Commercial Distribution

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2022-02-15
• Device Publish Date: 2022-02-07

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• 15060456180345 - DIALISA 2MP: 2022-02-15DIALISA 2MP, DS2 Automated ELISA Processing System
• 15060456180345 - DIALISA 2MP: 2022-02-15 DIALISA 2MP, DS2 Automated ELISA Processing System