Tissue-Tek Genie® DUO 8484-M100

GUDID 00615233008671

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

SAKURA FINETEK U.S.A., INC.

Cytokeratin IVD, antibody

• Primary Device ID: 00615233008671
• NIH Device Record Key: e169c6a4-d334-4d8b-92db-f7541e609bb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue-Tek Genie® DUO
• Version Model Number: 8484-M100
• Catalog Number: 8484-M100
• Company DUNS: 179135769
• Company Name: SAKURA FINETEK U.S.A., INC.
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233008671 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

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: 2023-06-26
• Device Publish Date: 2023-06-16

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• 00615233008671: anti-Pan Cytokeratin [AE1/AE3/DC10] /CD31 [RM247] Antibody Cocktail, 1 RTU cartridge