AccessGUDID - DEVICE: Epredia (00673693235747)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Rapid Chrome™ Papanicolaou Staining Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9990020
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693235747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: The Rapid-Chrome™ Papanicolaou Staining Kit is specially designed to facilitate the staining of cytology specimens. It is ideally suited to quickly stain fine needle aspirates, and it also prevents cross-contamination of routine staining dishes from high-risk cases. With the Rapid-ChromeTM Papanicolaou Staining Kit, all of the reagents needed for Pap-stained cytology specimens 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. All reagents are sequentially aligned to allow the slide to be moved from one jar to the next.

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
HZJ	Stain, Papanicolau

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: 1605b4ad-0990-4372-be83-a3896ef925de
Public Version Date: September 12, 2024
Public Version Number: 1
DI Record Publish Date: September 04, 2024