Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693086974
• Version / Model: Xylene
• Catalog Number: 6601
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-23
• Public Version: 1
• Public Version Date: 2024-07-31
• Public Version Status: New
• Public Device Record Key: 9bf20cc2-46d4-4153-95ae-e2042b9f685c

Device Description

Clear-Rite, Citrus Clearing Solvent, Xylene Substitute, Xylene, and Toluene are a group of solvents known to act as clearing reagents in the histology laboratory for tissue processing and staining. These clearing reagents are used to “clear” tissue or make it permeable to paraffin in tissue processing. In staining, Clearants are used after alcohol which dehydrates the tissue to enable the slide to be cover slipped with a resinous mounting media.

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
KEM	Agent, Clearing	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43781	Xylene solution IVD	A xylene solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693086974	GS1