Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693080040
• Version / Model: Bouin's fluid
• Catalog Number: 57211
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-25
• Public Version: 1
• Public Version Date: 2024-08-02
• Public Version Status: New
• Public Device Record Key: bf0c5e2a-3e6b-4153-bfff-289b36dc656a

Device Description

Bouin’s Fluid is used as a primary fixative or as a mordant when doing special stains such as Masson’s Trichrome.

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
IGN	Fluid, Bouin'S	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32948	Bouin's solution IVD	A solution typically prepared with saturated picric acid, formaldehyde, and glacial acetic acid intended to be used as a fixative in the processing of biological tissues and clinical specimens. Bouin?s solution is frequently used as a fixative for chromosomes undergoing mitosis or meiosis in soft or delicate tissues such as testes, or gastrointestinal (GI) tract and endocrine tissues.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693080040	GS1