Total Protein
3 catalogue numbers from 11929917216, listed by Roche Diagnostics Gmbh, Germany, under Biuret (Colorimetric), Total Protein. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | CEK |
| Device type | Biuret (Colorimetric), Total Protein |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1635 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-20 |
| Record revised | 2020-11-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 25 °C |
| Distribution end date | 2019-11-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11929917216 | Withdrawn | |
| 12000903216 | Withdrawn | |
| 12000920216 | Withdrawn |
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 |
| Alinity | Abbott Ireland | 2 |
| Pointe Total Protein Reagent | Horiba Instruments Incorporated | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Atellica CH Total Protein_2 | Siemens Healthcare 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.