ImmuChem Cortisol Coated Tube 125I RIA Kit

Basic Information

• Brand Name: ImmuChem Cortisol Coated Tube 125I RIA Kit
• Primary DI: 00817830022306
• Version / Model: 07221102
• Catalog Number: 07221102
• Company Name: MP BIOMEDICALS, LLC
• Labeler DUNS: 137825928
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: bf8fc24d-7d56-4641-aa90-a5d1cbe53c97

Device Description

Radioimmunoassay for the quantitative determination of Cortisol in human serum or plasma.

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
CGR	RADIOIMMUNOASSAY, CORTISOL	Clinical Chemistry	862.1205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58367	Total cortisol IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen, using a radioimmunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817830022306	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K791835	000

Device Sizes

Type	Value	Unit	Text
Length	28	Centimeter

Storage Conditions

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