Pantex Universal 635

GUDID 10850039602266

Color Development Reagent EIA 1 - 15mL

Pantex

Total testosterone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 10850039602266
• NIH Device Record Key: 8b59ef60-acf1-4e2b-9b8b-4bd83a998a77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pantex Universal
• Version Model Number: 1 Universal
• Catalog Number: 635
• Company DUNS: 072296809
• Company Name: Pantex
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com
• Phone: 1-310-828-7423
• Email: info@pantexba.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039602269 [Primary]
GS1	10850039602266 [Package]; Contains: 00850039602269; Package: Carton Box [1 Units]; In Commercial Distribution
GS1	20850039602263 [Package]; Contains: 00850039602269; Package: Carton Box [1 Units]; In Commercial Distribution

FDA Product Code

• CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

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: 2022-05-31
• Device Publish Date: 2022-05-23

On-Brand Devices [Pantex Universal]

• 00850039602689: Pantex Sample Collection Device single
• 10850039602273: Stopping Solution EIA 1 - 15mL
• 10850039602266: Color Development Reagent EIA 1 - 15mL
• 10850039602150: 10x Wash Solution EIA 1 - 50mL