IMMULITE 2000 Crotisol Kit Domestic 600T

Basic Information

• Brand Name: IMMULITE 2000 Crotisol Kit Domestic 600T
• Primary DI: 00630414167411
• Version / Model: 10901845
• Catalog Number: L2KCO6(D)
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• Labeler DUNS: 296822794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-15
• Public Version: 7
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 419a764a-f9bd-4a1c-9521-90202618024a

Device Description

IMMULITE 2000 Crotisol Kit Domestic 600T

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
54125	Total 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 total cortisol in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414167411	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K202826	000
K931409	000

Storage Conditions

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