Ferritin ELISA

Basic Information

• Brand Name: Ferritin ELISA
• Primary DI: B24225FERHUE010
• Version / Model: 25-FERHU-E01
• Catalog Number: 25-FERHU-E01
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-03
• Public Version: 4
• Public Version Date: 2022-09-20
• Public Version Status: Update
• Public Device Record Key: 225f61f3-17ca-4fce-9414-a6d202b484bb
• Distribution End Date: 2019-02-19

Device Description

This Ferritin ELISA is intended for use in the quantitative determination of ferritin in human serum. The assay is to be used in the diagnosis of diseases affecting iron metabolism.

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
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	866.5340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53717	Ferritin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of ferritin in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B24225FERHUE010	HIBCC

Customer Contacts

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

Storage Conditions

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