Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693235730
• Version / Model: Rapid-Chrome H&E Frozen Section Staining Kit
• Catalog Number: 9990001
• 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: b57e8aa1-912f-47b7-8cf9-ebdb514f5fce

Device Description

The Rapid-Chrome™ H&E Frozen Section Staining Kit simplifies the routine staining of frozen tissue sections from a cryostat. With the Rapid-Chrome™ Staining Kit, all of the reagents needed for H&E-stained frozen sections are supplied in one convenient, portable tray. Reagents are sequentially aligned so that the user can dip slides progressively from jar to jar.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
LEE	Stains, Dye 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	00673693235730	GS1