FastPack® Testo Kit (50)

Basic Information

• Brand Name: FastPack® Testo Kit (50)
• Primary DI: 10816467020034
• Version / Model: Testo Immunoassay
• Catalog Number: 25000009
• Company Name: QUALIGEN INC.
• Labeler DUNS: 959103565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 810016c6-de40-4b8e-a4af-b2fc286ca72d

Device Description

50 Test Non-Ported Testo Immunoassay Kit

Device Characteristics

• Single Use: Yes
• 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
61077	Total testosterone IVD, kit, chemiluminescent immunoassay	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 a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816467020034	GS1
Unit of Use	00816467020037	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101388	000

Storage Conditions

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