It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample.


Product Overview

It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample.
FREND - FRTE-AP


Device Description

A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total testosterone 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: CDZ

Device Name: Radioimmunoassay, Testosterones And Dihydrotestosterone

Device Class: 1

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: 862.1680

Third Party Flag: Y

Medical Specialty: CH


Device Identifiers

Device Id: 08809317540375

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


GMDN ®. © GMDN Agency 2005-2024.
Educational Resources
Videos