Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693204088
• Version / Model: Fast Flex™ Tissue Processing System - Kit 2 3x5L
• Catalog Number: 9802
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-23
• Public Version: 1
• Public Version Date: 2024-07-31
• Public Version Status: New
• Public Device Record Key: fe6ff3b8-6c2d-4b4f-b658-ecdc31cdd22d

Device Description

The Fast Flex Tissue Processing System was designed to accommodate a wide range of tissue processing demands. These reagents, when used together with the STP 420ES or Pathcentre tissue processors, will significantly reduce tissue processing times and produce very high-quality results. The Fast Flex Tissue Processing System provides optimal tissue processing and staining results based on the patented rotational technology in the main chamber of the STP 420ES and the chemically enhanced Fast Flex reagents. The Fast Flex Tissue Processing System also produces excellent tissue and staining results when used with the Pathcentre tissue processor. Tissue/chemical interactions, reactions, and diffusion rates are accelerated, and depending upon tissue thickness, fatty tissue such as breast, bowel, and lymph node process very efficiently within this system. Our experience has additionally shown that bloody tissues also process well, especially when Holding Solution is utilized in the grossing room. Traditional hematoxylin and eosin staining demonstrates well-delineated nuclear chromatin, as well as superb cytoplasmic contrast. Fast Flex Tissue Processing System Kit 2 3x5 L

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
63938	Histology tissue processing reagent kit IVD	A collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fixative (e.g., formalin), a dehydrating agent (e.g., alcohol) and a clearing reagent (e.g., xylene).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693204088	GS1