FREND

Basic Information

• Brand Name: FREND
• Primary DI: 08809317540184
• Version / Model: FREND PSA Plus
• Catalog Number: FRPS 025
• Company Name: NanoEnTek, Inc.
• Labeler DUNS: 687910463
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 4
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: 1b7b889c-90ab-4885-91ce-568b183609b4

Device Description

It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.

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
54666	Total prostate specific antigen (tPSA) IVD, kit, fluorescent 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 fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809317540184	GS1

Premarket Submissions

Submission Number	Supplement Number
K124056	000