N A1-Microglobulin Kit
Quantitative determination of a1-microglobulin in human urine on BN Systems
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 Products GmbH, Germany |
|---|---|
| FDA product code | JZG |
| Device type | System, Test, Beta-2-Microglobulin Immunological |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5630 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K904254 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 5) |
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 |
|---|---|---|
| 10446619 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 11 |
| Tinaquant 2Microglobulin | Roche Diagnostics Gmbh | 3 |
| Tina-quant ß2-Microglobulin | Roche Diagnostics Gmbh | 2 |
| Immulite/Immulite 1000 Systems Beta-2-Microglobulin Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2 |
| B2Microglobulin (B2M) | Randox Laboratories Limited | 2 |
| Advia® Chemistry B2M ß2-Microglobulin Reagents | Siemens Healthcare Diagnostics Inc | 1 |
| N Latex ß2-Microglobulin | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Optilite® Beta-2 Microglobulin Kit | The Binding Site Group Ltd. | 1 |
| Dimension Vista® ß2-Microglobulin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Optilite Beta 2 Microglobulin Urine Kit | The Binding Site Group Ltd. | 1 |
| Beta-2 Microglobulin Elisa | American Laboratory Products Company | 1 |
| Human Beta-2 Microglobulin Nanorid Radial Immunodiffusion Kit | The Binding Site Group Ltd. | 1 |
Showing 12 of 32. All products under System, Test, Beta-2-Microglobulin Immunological
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.