Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693230858
• Version / Model: Cytoblock Kit
• Catalog Number: 7401150
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-04
• Public Version: 1
• Public Version Date: 2024-08-12
• Public Version Status: New
• Public Device Record Key: aec1af81-b27d-472c-bf71-0db5cad4bc8e

Device Description

The Cytoblock system is designed to facilitate the preparation of paraffin-embedded cell suspensions, cell aggregates, and tissue fragments. The Cytoblock system can also be used to process tissue biopsies and fragments which are difficult or impossible to process using other techniques.

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
LEA	Preservative, Cytological	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62706	Agar powder IVD	A gelling agent intended to be used to create a solid culture medium for the isolation of single microbial colonies. It is presented as a powdered substance which is added to a heated liquid preparation which cools to form a solid medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693230858	GS1