FREND

Basic Information

• Brand Name: FREND
• Primary DI: 08809317540382
• Version / Model: FRT4-AP
• Catalog Number: FRT4AP 020
• Company Name: NanoEnTek, Inc.
• Labeler DUNS: 687910463
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-04
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 49a894eb-8c19-43e9-a873-81b9d73a80a5

Device Description

It is used for the quantitative determination of free thyroxine(free t4) 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
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	862.1695	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54414	Free thyroxine (FT4) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809317540382	GS1

Premarket Submissions

Submission Number	Supplement Number
K152422	000