Ceruloplasmin
The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The assay is intended for professional use only. For In…
The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The assay is intended for professional use only. For In Vitro diagnostic use.
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
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 | Sentinel CH. SPA, Italy |
|---|---|
| FDA product code | JFR |
| Device type | Indirect Copper Assay, Ceruloplasmin |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5210 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K051456 |
| Record published | 2018-11-15 |
| Record revised | 2026-05-27 (version 4) |
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 | Special storage condition: Store between 2 and 8 degrees Celsius |
| Sizes | Total volume 108 ml |
| Distribution end date | 2026-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11065N | Total Volume 108 ml | In distribution |
| A26842 | Total Volume 108 ml | Withdrawn |
Same Product Code
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051456 | 2005-10-21 |
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.