Pantex P635ST

Basic Information

• Brand Name: Pantex P635ST
• Primary DI: 00850039602245
• Version / Model: P635ST
• Catalog Number: 635
• Company Name: Pantex
• Labeler DUNS: 072296809
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-23
• Public Version: 5
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: c2564a88-1d11-49a2-8d4b-394dba748bfb

Device Description

Salivary Testosterone EIA Conjugate Buffer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	862.1680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58379	Total testosterone IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total testosterone in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850039602242	GS1	Carton Box	1	Not in Commercial Distribution	2023-02-17
Primary	00850039602245	GS1
Package	20850039602249	GS1	Carton Box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius