Tissue-Tek Genie® CISH

Basic Information

• Brand Name: Tissue-Tek Genie® CISH
• Primary DI: 00615233010230
• Version / Model: 9809-G006
• Catalog Number: 9809-G006
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-06-14
• Public Version: 2
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: 14a07b5c-991f-45df-9221-884b7fe4540a

Device Description

User-Fillable Cartridges for CISH Amplification Linker

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63042	Assay container IVD, reusable	A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures (e.g., rinsing of paraffin embedded tissues), or on-board automated liquid handling instruments or analysers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00615233010223	GS1
Primary	00615233010230	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]