Dewax Solution 2, DS2 Kit

Basic Information

• Brand Name: Dewax Solution 2, DS2 Kit
• Primary DI: 00847627036728
• Version / Model: OPRI6003KT60
• Company Name: BIOCARE MEDICAL LLC
• Labeler DUNS: 806617825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-17
• Public Version: 1
• Public Version Date: 2025-01-27
• Public Version Status: New
• Public Device Record Key: 8e4dff42-cfe4-48f0-912b-a454f9588b0e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62847	Dewaxing solution IVD	A substance intended to be used to remove paraffin wax from formalin-fixed, paraffin-embedded biological tissues or clinical specimens for subsequent in vitro diagnostic (IVD) testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847627036728	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 2 – 8 Degrees Celsius