Pantex P631SC 631

GUDID 00850039602009

Gargg Plate - 96 Wells

Pantex

Total cortisol IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850039602009
• NIH Device Record Key: 3495dcdc-7e04-43d1-97f7-6a01749808fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pantex P631SC
• Version Model Number: P631SC
• Catalog Number: 631
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039602009 [Primary]
GS1	10850039602006 [Package]; Package: Foil [1 Units]; In Commercial Distribution
GS1	40850039602007 [Package]; Package: Foil [1 Units]; In Commercial Distribution

FDA Product Code

• NHG: Enzyme Immunoassay, Cortisol, Salivary

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 P631SC]

• 10850039602143: Stopping Solution EIA 1 #12ml
• 10850039602136: Color Development Reagent EIA 1 #12ml
• 10850039602129: Salivary Cortisol EIA Conjugate Buffer
• 10850039602112: Salivary Cortisol EIA Antibody
• 10850039602105: Salivary Cortisol EIA HRP Enzyme Conjugate
• 10850039602099: Salivary Cortisol EIA Control Level 2
• 10850039602082: Salivary Cortisol EIA Control Level 1
• 10850039602075: Salivary Cortisol EIA Calibrator 30 ng/mL
• 10850039602068: Salivary Cortisol EIA Calibrator 10 ng/mL
• 10850039602051: Salivary Cortisol EIA Calibrator 3.0 ng/mL
• 10850039602044: Salivary Cortisol EIA Calibrator 1.0 ng/mL
• 10850039602037: Salivary Cortisol EIA Calibrator 0.3 ng/mL
• 10850039602020: Salivary Cortisol EIA Calibrator 0.1 ng/mL
• 10850039602013: Salivary Cortisol EIA Calibrator 0 ng/mL
• 00850039602009: Gargg Plate - 96 Wells