Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693228268
• Version / Model: TBD-1 Decalcifier
• Catalog Number: 6764002
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-26
• Public Version: 1
• Public Version Date: 2024-08-05
• Public Version Status: New
• Public Device Record Key: 022e9d03-e27a-4264-8721-16bdb7b63ecf

Device Description

Decalcifying Solutions are for in vitro diagnostic used for the removal of calcium in pathological 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
KDX	Solution, Decalcifier, Acid Containing	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57785	Decalcifying solution IVD	A solution intended to be used as a decalcifying agent in the processing of clinical specimens and biological tissues for subsequent in vitro diagnostic analysis. It is typically in the form of an inorganic acid [e.g., hydrochloric acid (HCl)], organic acid [e.g., formic acid (CH2O2)] or a chelating agent [e.g., ethylenediaminetetraacetic acid (EDTA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693228268	GS1