AccessGUDID - DEVICE: Epredia (00673693089340)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Congo Red Solution
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88005
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693089340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: The Amyloid Stain kit is a special stain technique to identify amyloid in tissue sections. Amyloid, a fiber-like protein, can be stained with Congo Red solution. Sodium Hydroxide is added to the solution to break down hydrogen bonds between adjacent amyloid fibers allowing more bonding sites for the Congo Red. A light counterstain with Mayer’s hematoxylin allows contrast. Amyloid can be best detected by the use of green birefringence under a polarized lens of a light microscope. Care should be taken to section tissue sections at a thickness of 7-10 microns for optimal staining.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ICH	Congo Red

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba9f2526-d584-4d07-8314-b6835b93093e
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024