The Access Cortisol Calibrators are intended to calibrate the Access Cortisol assay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Access Cortisol Calibrators - 33605
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free cortisol 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: JIS
Device Name: Calibrator, Primary
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 862.1150
Third Party Flag: N
Medical Specialty: CH
Device Identifiers
Device Id: 15099590231101
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
