FastPack® IP Total PSA Kit (90)

Basic Information

• Brand Name: FastPack® IP Total PSA Kit (90)
• Primary DI: 30816467020014
• Version / Model: TPSA Immunoassay
• Catalog Number: 25000057
• Company Name: QUALIGEN INC.
• Labeler DUNS: 959103565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 90
• Record Status: Published
• Publish Date: 2017-09-14
• Public Version: 4
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: fa4af732-a206-4823-9c82-d1e6ea4f5a51

Device Description

90 Test Ported TPSA 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
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54665	Total prostate specific antigen (tPSA) 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 prostate specific antigen (tPSA) 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	30816467020014	GS1
Unit of Use	00816467020013	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K003094	000

Storage Conditions

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