AccessGUDID - DEVICE: Epredia (00673693236348)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Kwik-Diff™ Stain Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9990700
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693236348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: "This staining kit simplifies quick differential staining blood smears and fine needle aspirates with its compact size making it specially ideal for FNA carts. With the Rapid-Chrome Kwik- Diff Staining Kit, all of the necessary reagents and accessories are supplied in one convenient, portable tray. Reagents are sequentially aligned so that the user can dip slides progressively from jar to jar. Additionally, die-cut slots in the tray base accommodate jar lids in order to reduce potential cross-contamination of reagents as well as required counter space. This kit can stain approximately 100 slides, although the actual number may vary based upon sample type and thickness."

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:	Yes
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: 6453c40f-94ba-4b65-b1ac-9de3c5d8dd52
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024