Tissue-Tek Genie®
anti-Terminal Deoxyribonucleotidyl Transferase Mouse Monoclonal Antibody [SEN28], 1 RTU cartridge
7manufacturers in China registered for this device type
330catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jilin (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Shenzhen Dakewe BIO-Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shenzhen Dartmon Biotechnology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Fuzhou Maixin Biotech Co., Ltd. | Fuzhou | Fujian | Manufacturer | 3 |
Record
| Listed by | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | NJT |
| Device type | Immunohistochemistry Reagents And Kits |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1860 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-01 |
| Record revised | 2023-10-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2026-03-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
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| 8295-M250 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostic BioSystems | Diagnostic Biosystems | 2,453 |
| Thermo Scientific | Richard-Allan Scientific LLC | 866 |
| IHC | Slmp, LLC | 350 |
| Bond | Leica Biosystems Newcastle Ltd | 327 |
| Novocastra | Leica Biosystems Newcastle Ltd | 272 |
| Genemed® | Sakura Finetek U.S.A., Inc. | 167 |
| Epredia | Richard-Allan Scientific LLC | 46 |
| Prame [EPR20330] | Biocare Medical, LLC | 14 |
| Cyclin D1 | Biocare Medical, LLC | 14 |
| Napsin A | Biocare Medical, LLC | 13 |
| Tissue-Tek Genie® DUO | Sakura Finetek U.S.A., Inc. | 13 |
| SOX10 (M) | Biocare Medical, LLC | 12 |
Showing 12 of 3,569. All products under Immunohistochemistry Reagents And Kits
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.