Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693483216
• Version / Model: Hematoxylin 7211
• Catalog Number: 7211L
• 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: defa5ab0-9321-4eef-8749-ab34850d9ad5

Device Description

Hematoxylin 7211 is a rapid, progressive hematoxylin. The product is a hybrid between classical Harris and Gill formulations: it provides the classic intensity and hues of a Harris hematoxylin and the rapid progressive qualities of a Gill hematoxylin. Differentiation is not required, but if desired Clarifier 1 should be used. Clarifier 1 will eliminate any background staining that may be caused by the use of excess gelatin or other adhesives in the water bath. Clarifier 2 can be used as well; however, a shorter immersion time is required. Hematoxylin 7211 does not have an affinity for acid mucopolysaccharide (mucin) staining, as do some other hematoxylin formulations. It provides consistent, well-delineated nuclear staining results.

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
HYJ	Hematoxylin	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	00673693483216	GS1