Tissue-Tek Genie® CISH 9809-G006

GUDID 00615233010223

User-Fillable Cartridges for CISH Amplification Linker

SAKURA FINETEK U.S.A., INC.

Assay container IVD, reusable

• Primary Device ID: 00615233010223
• NIH Device Record Key: 14a07b5c-991f-45df-9221-884b7fe4540a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek Genie® CISH
• Version Model Number: 9809-G006
• Catalog Number: 9809-G006
• Company DUNS: 179135769
• Company Name: SAKURA FINETEK U.S.A., INC.
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com
• Phone: (310) 972-7800
• Email: TS@sakuraus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233010223 [Unit of Use]
GS1	00615233010230 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits
• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by SAKURA FINETEK U.S.A., INC.

• 00615233011008 - Tissue-Tek Prisma®: 2024-10-21 H&E Stain Kit #2
• 04946433600584 - Tissue-VIP® 6 AI: 2024-10-21 Vacuum Infiltration Processor, 230 VAC, 50/60 Hz, 6.0 Amps
• 00615233010605 - Tissue-Tek Genie®: 2024-05-27 anti-CD10 Rabbit Monoclonal Antibody [QR021], 10 RTU capsules
• 00615233010612 - Tissue-Tek Genie®: 2024-05-27 anti-CD10 Rabbit Monoclonal Antibody [QR021], 1 RTU cartridge
• 00615233011312 - Tissue-Tek Genie®: 2024-05-27 anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14], 1 RTU cartridge
• 00615233011350 - Tissue-Tek Genie®: 2024-05-27 anti-SATB2 Rabbit Monoclonal Antibody [QR023], 10 RTU capsules
• 00615233011367 - Tissue-Tek Genie®: 2024-05-27 anti-SATB2 Rabbit Monoclonal Antibody [QR023], 1 RTU cartridge
• 00615233011329 - Tissue-Tek Genie®: 2024-05-20 anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14], 10 RTU capsules