Prealbumin
2 catalogue numbers from 5950902190, listed by Roche Diagnostics Gmbh, Germany, under Prealbumin, Antigen, Antiserum, Control. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JZJ |
| Device type | Prealbumin, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5060 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-18 |
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 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5950902190 | In distribution | |
| 08252645190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 8 |
| Architect | Abbott Laboratories | 2 |
| Antiserum to Human Prealbumin | Kent Laboratories, Inc. | 1 |
| K-Assay® Prealbumin Calibrator | Kamiya Biomedical Company LLC | 1 |
| Atellica CH Prealbumin (Palb) | Siemens Healthcare Diagnostics Inc | 1 |
| Alinity | Abbott Medical | 1 |
| DImension Vista® Prealbumin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Yumizen C1200 Prealbumin | Horiba ABX SAS | 1 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 1 |
| Human Prealbumin Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| N Antiserum to Human Prealbumin | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Alinity | Abbott Ireland | 1 |
Showing 12 of 24. All products under Prealbumin, Antigen, Antiserum, Control
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.