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
Device Description
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.
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 IdentifiersDevice 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