The Access Testosterone Calibrators are intended to calibrate the Access Testosterone assay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems.

The Access Testosterone Calibrators are intended to calibrate the Access Testosterone assay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems.
Access Testosterone Calibrator - 33565

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free testosterone in a clinical specimen, using an enzyme immunoassay (EIA) method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 15099590231293

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