AccessGUDID - DEVICE: Epredia (00673693069564)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Three-Step Stain Set
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3300
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693069564
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: The Three-Step Stain Set is comprised of three components: a methanol fixative (Fixative), an aqueous eosin solution (Solution A), and an aqueous methylene blue/azure A solution (Solution B). The staining solutions consist of xanthene and thiazine dyes, exhibiting both anionic and cationic properties, respectively. Cationic cellular components, such as erythrocytes and eosinophilic granules, share an affinity for the anionic dye of Solution A. The negatively charged phosphate groups of DNA and basophilic granules of the cytoplasm have an affinity for the polychromatic cationic dyes of Solution B. The aqueous stain formulations function to dissociate and activate the dye ions, allowing them to chemically bond with specific cellular components. When staining blood and bone marrow smears, the pH of the staining solutions is a critical factor

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
HYF	Giemsa Stain

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: fa285279-bc03-4f54-975b-261d2b4f4dbe
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024