Mono Mo A-Hu Prostate-Specific Membrane Antigen Cl 3e6
Monoclonal Mouse Anti-Human Prostate-Specific Membrane Antigen Clone 3E6
7manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | 2024-08-06 (version 3) |
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 to 1 ml |
| Distribution end date | 2024-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M3620 | Total Volume 0.2 ml | Withdrawn |
| M3620 | Total Volume 1 ml | Withdrawn |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.