Chromoplex
ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of…
ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
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 | Leica Biosystems Newcastle Ltd, United Kingdom |
|---|---|
| FDA product code | NJT |
| Device type | Immunohistochemistry Reagents And Kits |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1860 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS9477 | 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 |
| Tissue-Tek Genie® DUO | Sakura Finetek U.S.A., Inc. | 13 |
Showing 12 of 3,569. All products under Immunohistochemistry Reagents And Kits
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-31 | Class II | Process control | The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide. | 1) 2,304 units; 2) 37 units | 2017-08-14 |
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.