Cortisol Saliva Luminescence Immunoassay

Basic Information

• Brand Name: Cortisol Saliva Luminescence Immunoassay
• Primary DI: 04049325007734
• Version / Model: RE62119
• Catalog Number: RE62119
• Company Name: IBL International GmbH
• Labeler DUNS: 312694785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: da6c2ad5-dd6f-49ec-9e13-957f2b87f76b

Device Description

Cortisol Saliva Luminescence Immunoassay Assay Kit - 10x96 Determinations

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHG	Enzyme Immunoassay, Cortisol, Salivary	Clinical Chemistry	862.1205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62263	Free cortisol IVD, kit, chemiluminescent immunoassay	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 a chemiluminescent immunoassay method. It is used as an aid in the diagnosis and treatment of adrenal disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049325007734	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius