IDG/Sanzay
For the quantitative determination of total protein concentration in human serum.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | IDG/Sanzay Corporation |
|---|---|
| FDA product code | CEK |
| Device type | Biuret (Colorimetric), Total Protein |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1635 |
| 510(k) | K864743 |
| Record published | 2024-01-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Sizes | Total volume 100 to 120 ml; total volume 1 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Total Volume 100 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 17 |
| Synermed® | Infrared Laboratory Systems LLC | 10 |
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 5 |
| AU | Beckman Coulter, Inc. | 5 |
| Pointe Scientific, Inc. Total Protein | Horiba Instruments Incorporated | 5 |
| Synchron | Beckman Coulter, Inc. | 3 |
| Total Protein 2 (TP 2) | Randox Laboratories Limited | 3 |
| Total Protein | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 2 |
| Pointe Total Protein Reagent | Horiba Instruments Incorporated | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
Showing 12 of 61. All products under Biuret (Colorimetric), Total Protein
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.