STELLUX® Chemi Human Insulin ELISA

Basic Information

• Brand Name: STELLUX® Chemi Human Insulin ELISA
• Primary DI: B24280INSHUCH010
• Version / Model: 80-INSHU-CH01
• Catalog Number: 80-INSHU-CH01
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 1
• Public Version Date: 2020-07-27
• Public Version Status: New
• Public Device Record Key: 0e8a6aab-e1db-4320-983f-535997492fb5

Device Description

The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use.

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: Yes
• 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
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	862.1405	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54237	Insulin IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin 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	B24280INSHUCH010	HIBCC

Customer Contacts

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

Storage Conditions

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