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 Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable 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 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| TS@sakuraus.com | |
| Phone | (310) 972-7800 |
| 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.
| 00615233011299 - Tissue-Tek Genie® | 2023-11-06 anti-p53 Mouse Monoclonal Antibody [DO-7], 1 RTU cartridge |
| 00615233011305 - Tissue-Tek Genie® | 2023-11-06 anti-p53 Mouse Monoclonal Antibody [DO-7], 10 RTU capsules |
| 00615233010629 - Genemed® | 2023-10-24 anti-HER2 Rabbit Monoclonal Antibody [EP3], Ready-To-Use, 15 mL |
| 00615233011183 - Genemed® | 2023-10-24 anti-PRAME Rabbit Monoclonal Antibody [QR005], Concentrate, 1 mL |
| 00615233011190 - Genemed® | 2023-10-24 anti-PRAME Rabbit Monoclonal Antibody [QR005], Ready-To-Use, 15 mL |
| 00615233008107 - Tissue-Tek Genie® | 2023-07-25 DAB Cleaning Consumables Kit |
| 00615233008510 - Tissue-Tek Genie® | 2023-07-25 anti-OCT.2 Rabbit Monoclonal Antibody [EP284], 10 RTU capsules |
| 00615233008527 - Tissue-Tek Genie® | 2023-07-25 anti-OCT.2 Rabbit Monoclonal Antibody [EP284], 1 RTU cartridge |
Trademark Results [Tissue-Tek Genie]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSUE-TEK GENIE 88367584 not registered Live/Pending |
Sakura Finetek U.S.A., Inc. 2019-04-02 |
 TISSUE-TEK GENIE 78452423 3551786 Live/Registered |
Sakura Finetek U.S.A., Inc. 2004-07-18 |
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