FREND Free T4 FRT4AP 020

GUDID 08809317540382

It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.

NanoEnTek, Inc.

Free thyroxine (FT4) IVD, reagent

• Primary Device ID: 08809317540382
• NIH Device Record Key: 49a894eb-8c19-43e9-a873-81b9d73a80a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREND Free T4
• Version Model Number: FRT4-AP
• Catalog Number: FRT4AP 020
• Company DUNS: 687910463
• Company Name: NanoEnTek, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809317540382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152422

FDA Product Code

• CEC: Radioimmunoassay, Free Thyroxine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-07-22
• Device Publish Date: 2018-05-04

On-Brand Devices [FREND Free T4]

• 08809317540382: It is used for the quantitative determination of free thyroxine(free t4) in human specimen using
• 08809317540191: It is used for the quantitative determination of free thyroxine(free t4) in human specimen using