Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693088091
• Version / Model: Bluing Reagent
• Catalog Number: 7341
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-30
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: cc6fe9b0-9143-458f-bf3b-d0cd98efb6df

Device Description

Bluing Reagent is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens. Bluing Reagent is a buffered alkaline rinse that shifts the final hue of hematoxylin from reddish-blue to traditional blue-purple. Unlike ammonia water and lithium carbonate, Bluing Reagent inhibits pH changes that can adversely affect nuclear detail and “crispness”.

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: Yes
• 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
LED	Stains, Chemical Solution	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693088091	GS1