Epidermal Growth Factor Receptor (Egfr)
2 catalogue numbers from ACI063CK, listed by Biocare Medical, LLC, 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
2catalogue numbers in this listing
9recalls 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 | Biocare Medical, LLC, United States |
|---|---|
| FDA product code | NJT |
| Device type | Immunohistochemistry Reagents And Kits |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1860 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-23 |
| Record revised | 2023-04-26 (version 2) |
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 |
|---|---|---|
| ACI063CK | In distribution | |
| ACI063AK | 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
6 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-10 | Class II | Pending | Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patie | 8 | 2020-12-02 |
| 2018-04-24 | Class II | Material/Component Contamination | Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. | 43 units | 2020-07-14 |
| 2018-03-15 | Class II | Other | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components. | 11 | 2020-04-22 |
| 2016-03-31 | Class III | Labeling mix-ups | Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer. | 93 | 2016-06-20 |
| 2015-09-08 | Class II | Device Design | Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA. | 151 units | 2016-01-11 |
| 2015-05-06 | Class III | Labeling mix-ups | Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. | 19 units | 2015-06-04 |
| 2015-03-17 | Class II | Unknown/Undetermined by firm | A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life. | 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and | 2015-06-15 |
| 2014-12-12 | Class II | Incorrect or no expiration date | Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed. | 59 | 2015-03-30 |
| 2012-03-13 | Not classified | Nonconforming Material/Component | Reports of sporadic failure of specific lots of Vina Green Chromogen Kit, either through crystal formation that obscures positive staining, color not right, or a complete fading of staining by the chromogen. | 74 kits | 2012-09-20 |
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.