Iron Reagent Set

Basic Information

• Brand Name: Iron Reagent Set
• Primary DI: 00812137011992
• Version / Model: R1 x 500mL, R2 x 15mL
• Catalog Number: 501-412
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Labeler DUNS: 048144997
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 3836e05d-fb2e-4aba-9a99-420b89bdf5ef

Device Description

For the quantitative determination of iron in serum. For in vitro diagnostic use only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	862.1410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54762	Iron IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of iron in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812137011992	GS1
Unit of Use	00812137012326	GS1

Customer Contacts

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

Storage Conditions

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