Mono Mo A-Hu Prostein Cl 10e3
Monoclonal Mouse Anti-Human Prostein Clone 10E3
7manufacturers in China registered for this device type
1catalogue number
11recalls 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 | Agilent Technologies, Inc, United States |
|---|---|
| FDA product code | NJT |
| Device type | Immunohistochemistry Reagents And Kits |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-17 |
| Record revised | 2025-04-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 0.2 ml |
| Distribution end date | 2025-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M3615 | Total Volume 0.2 ml | Withdrawn |
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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 045036=632, 065022=805 &, 085032=274 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 035196=163, 055032=168 &, 075115=124 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 035194=19, 055030=39 &, 065142=20 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 045038=419 & 065140=223 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 035293=76, 055031=183 &, 075114=98 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 045037=113 & 065139=122 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 045172=199 & 075112=112 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 045175=14, 065144=6 &, 085147=0 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 065021=136 & 085031=43 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 085146=0 & 065143=8 | 2007-01-29 |
| 2005-10-14 | Not classified | Other | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | Lots 045173=961& 075113=313 | 2007-01-29 |
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.