AccessGUDID - DEVICE: Tissue-Tek Genie® DUO (00615233008671)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek Genie® DUO
Version or Model: 8484-M100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8484-M100
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 00615233008671
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: anti-Pan Cytokeratin [AE1/AE3/DC10] /CD31 [RM247] Antibody Cocktail, 1 RTU cartridge

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:	No
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?
57079	Cytokeratin IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen.	Active	false
56970	CD31 endothelial cell marker IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD31 endothelial cell marker in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

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: e169c6a4-d334-4d8b-92db-f7541e609bb3
Public Version Date: June 26, 2023
Public Version Number: 1
DI Record Publish Date: June 16, 2023