Ricca Chemical Company®

Basic Information

• Brand Name: Ricca Chemical Company®
• Primary DI: 00192024029324
• Version / Model: 2780-16
• Catalog Number: 2780
• Company Name: Ricca Chemical Company, LLC
• Labeler DUNS: 020335667
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-04
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: bd201374-7d6e-4e58-b463-e6f6d52c6a88

Device Description

Ehrlich Aldehyde Reagent, Wallace-Diamond Formulation, for Urobilinogen Determination

Device Characteristics

• Single Use: No
• 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: 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
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1785	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66282	Urine urobilinogen indicator reagent IVD	A substance or reactant intended to be used for the presumptive detection of urobilinogen in urine. It is a yellow-coloured reagent (commonly referred to as Ehrlich’s reagent) which results in the formation of a pink-red solution in the presence of urobilinogen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192024029324	GS1

Customer Contacts

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