Architect
Ceruloplasmin
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JFR |
| Device type | Indirect Copper Assay, Ceruloplasmin |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5210 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2024-02-21 (version 3) |
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; Handling environment temperature up to 29 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6K91-30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ceruloplasmin | Sentinel CH. SPA | 2 |
| Alinity | Abbott Laboratories | 1 |
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.