Pantex P635ST 635

GUDID 10850039602228

Salivary Testosterone EIA HRP Enzyme

Pantex

Total testosterone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 10850039602228
• NIH Device Record Key: fdf2d921-d854-48d1-9125-fd00e25bb77b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pantex P635ST
• Version Model Number: P635ST
• 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	00850039602221 [Primary]
GS1	10850039602228 [Package]; Contains: 00850039602221; Package: Carton Box [1 Units]; In Commercial Distribution
GS1	20850039602225 [Package]; Contains: 00850039602221; 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 P635ST]

• 10850039602259: Salivary Testosterone EIA Assay Diluent
• 10850039602242: Salivary Testosterone EIA Conjugate Buffer
• 10850039602235: Salivary Testosterone EIA Antibody
• 10850039602228: Salivary Testosterone EIA HRP Enzyme
• 10850039602211: Salivary Testosterone EIA Stock Control (20,000 pg/mL)
• 10850039602204: Salivary Testosterone EIA Stock Calibrator (62,500 pg/mL)