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


Product Overview

It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.
FREND - FRT4-AP


Device Description

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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: CEC

Device Name: Radioimmunoassay, Free Thyroxine

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1695

Third Party Flag: Y

Medical Specialty: CH


Device Identifiers

Device Id: 08809317540382

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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