The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems.

The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems.
Access Testosterone - 33560

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.

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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: 15099590231347

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