Tissue-Tek Xpress® x50 7760
GUDID 00615233081728
Processing Reagent Set
SAKURA FINETEK U.S.A., INC.
Histology tissue processing reagent kit IVD| Primary Device ID | 00615233081728 |
| NIH Device Record Key | 2d4561b3-19dd-46e9-8111-4cdb5c29b369 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tissue-Tek Xpress® x50 |
| Version Model Number | 7760 |
| Catalog Number | 7760 |
| 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 | true |
| 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 | +1(310)972-7800 |
| TS@sakuraus.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00615233081728 [Primary] |
FDA Product Code
| LDZ | FIXATIVE, ALCOHOL CONTAINING |
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 | 2019-12-23 |
| Device Publish Date | 2019-12-15 |
Devices Manufactured by SAKURA FINETEK U.S.A., INC.
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| 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 |
Trademark Results [Tissue-Tek Xpress]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSUE-TEK XPRESS 78266653 2929777 Live/Registered |
Sakura Finetek, U.S.A., Inc. 2003-06-24 |
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