Confirm Anti-Synaptophysin [SP11] Rabbit Monoclonal Primary Antibody
Catalogue number 05479304001, listed by Ventana Medical Systems, Inc., United States, under Immunohistochemistry Reagents And Kits. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
19recalls on this code
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 | Ventana Medical Systems, 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, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-29 |
| Record revised | 2025-07-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05479304001 | 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
18 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2024-06-27 | Class II | Unknown/Undetermined by firm | Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. | 22,839 kits | |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 75 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 14,655 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 11,712 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 8211 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 461 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 2172 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 354 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 3068 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 96 units | 2021-11-22 |
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 10 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 748 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 3122 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 72730 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 18 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 1980 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 5040 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 518 units | 2021-11-22 |
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 12028 units | 2021-11-22 |
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.