Dimension Vista® Flex® Reagent Cartridge A2MAC
For the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® System
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Shandong (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 |
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | DEB |
| Device type | Alpha-2-Macroglobulin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5620 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K081249 |
| Record published | 2016-09-24 |
| Record revised | 2024-12-06 (version 6) |
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 |
| Distribution end date | 2023-03-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10465670 | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 2 |
| α2-Makroglobulin Elisa | Immundiagnostik, Inc. | 2 |
| Alpha2-Macroglobulin | Diagam | 2 |
| Human alpha 2 macroglobulin Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| N Antiserum to Human a2-Macroglobulin | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Antiserum to Human Alpha 2 Macroglobulin | Kent Laboratories, Inc. | 1 |
| Immage | Beckman Coulter, Inc. | 1 |
| Optilite Alpha-2-macroglobulin Kit | The Binding Site Group Ltd. | 1 |
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.