Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693088046
• Version / Model: Modified Harris Hematoxylin (Series R)
• Catalog Number: 72711
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-04
• Public Version: 1
• Public Version Date: 2024-09-12
• Public Version Status: New
• Public Device Record Key: f2614236-9262-4e59-8f7b-c0f5af16172f

Device Description

Modified Harris Hematoxylin is an acidified, ready-to-use formulation that provides traditional nuclear staining results. Harris hematoxylin procedures require acid alcohol differentiation. The nuclear chromatin and cytoplasm are overstained and the acid alcohol is used to destain the cytoplasm and to remove excess stain from the nucleus. Staining times are typically in the 5-minute range. Epredia Differentiating Solution is recommended for use with Modified Harris Hematoxylin

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
HYK	Hematoxylin Harris'S	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	00673693088046	GS1