Atellica CH PreAlb
Prealbumin (PreAlb) Atellica CH - RGT 400T
3manufacturers in China registered for this device type
1catalogue number
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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K000661 |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11097617 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 8 |
| Architect | Abbott Laboratories | 2 |
| Prealbumin | Roche Diagnostics Gmbh | 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 |
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.