Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693088275
• Version / Model: OG-6 Papanicolaou Stain
• Catalog Number: 75225
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-09
• Public Version: 1
• Public Version Date: 2024-08-19
• Public Version Status: New
• Public Device Record Key: 67738d2e-8dae-438c-944f-74fb1f093929
• Distribution End Date: 2024-08-09

Device Description

OG-6 is a traditional formulation that, when used with various EA products, will provide familiar staining results for gynecological and non-gynecological specimens.

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
HZJ	Stain, Papanicolau	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	00673693088275	GS1