Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693088152
• Version / Model: Clarifier™ 1
• Catalog Number: 7441
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-30
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: f51ee917-8299-41f2-82c8-4913aacb3d62

Device Description

Clarifier™ 1 is a reagent designed to eliminate background staining sometimes caused by excessive adhesives in the water bath such as gelatin. Clarifier™ 1 selectively removes hematoxylin staining from excess adhesive without affecting nuclear staining. This product is only effective with progressive staining and should not be used with regressive stains. Clarifier™ 1 is designed for use after staining with progressive hematoxylins. After tissues have been sufficiently stained with a progressive hematoxylin, slides are removed from the stain and excess hematoxylin is removed by rinsing the sections in water. The sections are then placed into Clarifier™ 1 for 30 seconds to 1 minute. A 1-minute water rinse should follow as this stops the reaction and rinses excess acid from the tissue section. If Clarifier™ 1 is not successful in removing the background staining, use Clarifier™ 2 in its place with a possible time reduction.

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
LED	Stains, Chemical Solution	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43606	Differentiation solution IVD	A differentiation solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693088152	GS1