FREND

Basic Information

• Brand Name: FREND
• Primary DI: 08809317540016
• Version / Model: FREND TSH
• Catalog Number: FRTS 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5743c7cb-79b8-47e4-986a-4d829af57858

Device Description

It is used for the quantitative determination of Thyroid Stimulating Hormone 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
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	862.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54384	Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) 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	08809317540016	GS1

Premarket Submissions

Submission Number	Supplement Number
K131928	000