Leica Biosystems

Basic Information

• Brand Name: Leica Biosystems
• Primary DI: 10849832012525
• Version / Model: 000000000003801450
• Company Name: Leica Biosystems Richmond, Inc.
• Labeler DUNS: 082930884
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2024-12-19
• Public Version: 2
• Public Version Date: 2025-04-17
• Public Version Status: Update
• Public Device Record Key: 20bf830d-5862-4cfd-b5aa-55959f84f00d

Device Description

Formula R

Device Characteristics

• Single Use: No
• 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
KEO	FORMULATIONS, PARAFFIN, ALL	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57738	Paraffin-based embedding medium IVD	A paraffin-based embedding material intended to be used as an embedding medium in the processing of biological tissues or clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00849832012528	GS1
Primary	10849832012525	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify

Storage Conditions

• Type: Special Storage Condition, Specify