Tissue-Tek Genie® DUO
anti-AMACR [13H4] / p63 [MX013] / CK5/6 [D5/16B4] PIN Antibody Cocktail, 10 RTU capsules
7manufacturers in China registered for this device type
13catalogue 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 | 2021-12-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8487-C010 | In distribution | |
| 8480-C010 | In distribution | |
| 8482-M250 | In distribution | |
| 8486-M100 | In distribution | |
| 8480-M100 | In distribution | |
| 8484-C010 | In distribution | |
| 8484-M100 | In distribution | |
| 8482-C010 | In distribution | |
| 8486-C010 | In distribution | |
| 8487-M100 | In distribution | |
| 8485-C010 | In distribution | |
| 8837-K250 | In distribution | |
| 8485-M100 | In distribution |
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 |
| Tissue-Tek Genie® | Sakura Finetek U.S.A., Inc. | 330 |
| 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 |
| 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.